Atlas FDA

GCY

96 FDA 510(k) clearances · Product code

36 daysmedian time to decision
129 days90th percentile
96clearances measured

FDA profile

Official device name
Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Device class
Class I (low risk)
Regulation
21 CFR 878.4680
Medical specialty
General, Plastic Surgery
Adverse events (MAUDE)
2021: 216 · 2022: 96 · 2023: 90 · 2024: 74 · 2025: 182 · 2026: 80
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
REDYROB-CLOSED WOUND DRAINAGE SYSTEM (K972703)B.Braun Medical, Inc.1997-10-01
ODONTIT AUTOGENOUS BONE COLLECTION DEVICE (K971036)Interpore Intl.1997-06-03
CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500 (K963839)Cordis Corp.1996-12-12
PENROSE DRAIN MODELS 6001 - 6007 (K960099)Sil-Med Corp.1996-03-11
MACRO SUCTION TUBE MODEL NO 10061 (K950754)Dlp, Inc.1995-04-25
PRESSURE IRRIGATING SYSTEM (K936223)Level 1 Technologies, Inc.1994-05-12
AUTOVAC CLOSED WOUND SUCTION SYSTEM (K930615)Boehringer Laboratories1994-02-22
BIRTCHER GS-9480 INTEGRATED 3-CHIP CAMERA/XENON LIGHT SOURCE VISUALIZATION SYSTEM (K933319)Birtcher Medical Systems, Inc.1993-10-27
IMC 5.0MM IRRIGATION/ASPIRATION PROBE (K933305)Inman Medical Corp.1993-10-05
IMC 5.0MM IRRIGATION/ASPIRATION PROBE W/HOLES (K933306)Inman Medical Corp.1993-10-05
INMAN POOLE TIP SUCTION PROBE W/TUBING KIT (K933170)Inman Medical Corp.1993-09-16
POOLE TIP SUCTION PROBE (K931950)Mayaguez Medical Center1993-08-11
5.0 MM IRRIGATION/ASPIRATION PROBE (K931856)Mayaguez Medical Center1993-08-10
ORC TAPPERED IRRIGATING PROBE (K925024)O.R. Concepts, Inc.1993-05-21
# 9455 AND #9457 POOLE TIP SUCTION PROBE (K923908)O.R. Concepts, Inc.1993-05-17
ABDOVAC (TM), BELLOVAC (TM) AND EXUDRAIN (K920819)Astra Meditec AB1993-03-24
KENDALL TRU-CLOSE INFECTION CONTROL EVACUATOR (K925989)Kendall Healthcare Products Co. Div.Of Tyco Health1993-02-26
KENDALL TRU-CLOSE(TM) SUCTION RESERVOIR, 150 ML (K925749)Kendall Healthcare Products Co. Div.Of Tyco Health1993-02-01
J-VAC BULB SUCTION RESERVOIR (K922895)Johnson & Johnson Medical, Inc.1992-09-15
SOLCOVAC WOUND DRAINAGE SYSTEM (K915867)Solco Basle, Inc.1992-08-14
DAVOL 100CC SILICONE CLOSED WOUND DRAINAGE EVAC (K915536)Davol, Inc.1992-03-26
MICROTEK-HERITAGES SILICONE BULB EVACUATION SYSTEM (K910167)Microbio-Medics, Inc.1991-04-15
SEROMA-CATH CLOSE DRAINAGE SYSTEM (K905733)Dawn Medical1991-01-28
INAMED SMALL DRAIN SYSTEM (K901742)Inamed Development Co.1990-05-07
INAMED CONVERTIBLE DRAIN SYSTEM (K901764)Inamed Development Co.1990-05-07
INAMED CLOSED-WOUND DRAIN SYSTEM (K896491)Inamed Development Co.1990-01-08
CLOSED WOUND RESERVOIR (K896803)Westmark, Sterile Packing Systems, Inc. (Sps)1989-12-27
DRENOVAC (K883982)Iberhospitex, S.A.1989-02-23
CLOSED WOUND SUCTION DEVICE (K883472)Westmark, Sterile Packing Systems, Inc. (Sps)1988-10-18
AMBU TWIN PUMP - (MANUAL SUCTION PUMP) (K883433)Ambu, Inc.1988-09-02
HEMO SUC NUMBER HS100-HS205 (K881036)Instrumental Medico Croquevielle S.A.1988-06-20
WOUND-EVAC RS (K881012)Heritage Medical Products1988-03-17
HEYER-SCHULTE(R) 100CC & 400CC EXUDATE DISP. BAGS (K880650)Baxter Healthcare Corp1988-02-24
CLOSED WOUND DRAINAGE SYSTEMS (K874645)Hall Laboratories, Inc.1987-12-02
MAXIVAC(TM) CLOSED WOUND SUCTION DRAINAGE SYSTEM (K873332)American V. Mueller1987-09-08
DRAINOVAC COMPLETE CLOSED WOUND DRAINAGE DEVICE (K863482)Cardio Metrics, Inc.1986-10-14
URESIL 150CC BELLOWS RESERVOIR (K863562)Uresil Corp.1986-09-29
URESIL CLOSED DRAINAGE RESERVOIR (K863505)Uresil Corp.1986-09-18
NEW USE FOR ACUVAC SUCTION RESERVOIR 400CC (K863201)Allergan, Inc.1986-08-29
ASPIR-VAC DISPOSABLE SURGICAL DRAIN SYSTEM (K860981)Sun Technologies1986-05-02
BARD PARKER 150CC BELLOWS RESERVOIR (K854424)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-11-20
EMODREN EXCHANGEABLE PLASTIC BELLOWS (K853295)Parexel Intl. Corp.1985-08-20
SURGIDYNE SURGIFLO C.W.S. DRAIN PRODUCTS (K850634)Surgidyne, Inc.1985-06-28
ECONOMY 400 CWS WITH PVC DRAINS (K851084)C.R. Bard, Inc.1985-06-04
PROVAC WOUND HEALING/SUCTION SET (K850011)Medical Matrix, Inc.1985-05-21
CLOSED WOUND DRAIN (K850037)Consolidated Medical Equipment, Inc.1985-03-19
PERIMETER CLOSED WOUND RESEVOIR (K844921)Perimeter Medical, Inc.1985-03-18
CONCEPT C-VAC (K842710)Concept, Inc.1984-10-31
PROVAC WOUND DRAINAGE & HEALING SYS (K840913)Meyer Medical U.S.A., Inc.1984-04-24
TLS BULB DRAINAGE SYSTEM (K833586)Porex Medical1984-01-30
DISP. YANKAVER SURG. SUCTION INSTRUMENT (K830123)Narco Scientific1983-06-08
SUCTION RESERVOIR (K830607)Sil-Med Corp.1983-05-02
BBL STREP GROUPING KIT (K830510)Bd Becton Dickinson Vacutainer Systems Preanalytic1983-05-02
STRYKER CONSTAVAC (K823284)Stryker Corp.1983-01-14
MINI-VAC DRAIN SYSTEM (K822902)Angus Medical Co.1982-12-28
LARGE VOLUME CLOSED WOUND SUCTION DRAIN (K822032)American Heyer Schulte1982-08-16
ARGYLE VAC-U-CARE 100CC SUCTION RESERV (K821563)Sherwood Medical Co.1982-06-21
P-S SUCTION RESERVIOR (K820474)Pudenz-Schulte Medical Research Corp.1982-03-08
PS-ROUND SURG. DRAIN & CONNECTOR (K813377)Pudenz-Schulte Medical Research Corp.1982-01-05
WOUND-EVAC (K813341)Heritage Medical Products1981-12-18
DEPUY HEMODRAIN (K811557)Depuy, Inc.1981-07-20
SAF SINGLE-USE AEROSOL FILTER (K811203)Sorensen Research1981-05-21
VARIODRAIN (K810636)Colmed, Ltd.1981-05-01
SARNS MINI-SUCKER (K810416)3M Health Care, Sarns1981-03-05
ISPVAC TM (K802973)Innovative Surgical Products, Inc.1980-12-19
COS-UPHOFF INT'L DS-5 DRAINAGE SYSTEM (K802214)Cox-Uphuff Intl.1980-10-23
JACKSON-PRATT LARGE VOL. CLOSED WOUND (K801766)American Heyer Schulte1980-08-20
FRAZIER-FERGUSON SUCTION TUBES (DISP.) (K801612)Edward Weck, Inc.1980-08-04
P-S SURGICAL DRAIN (K801442)Pudenz-Schulte Medical Research Corp.1980-07-14
ACUVAC(TM) SUCTION RESERVOIR 400CC AND (K801350)Innovative Surgical Products, Inc.1980-07-14
P-S SUCTION RESERVOIR (K801443)Pudenz-Schulte Medical Research Corp.1980-07-14
ARGYLE VAC-U-CARE FLAT SILICONE WOUND T. (K801371)Sherwood Medical Co.1980-06-26
ARGYLE VAC-U-CARE 100CC SUCT. RESERVOIR (K801372)Sherwood Medical Co.1980-06-26
SNYDER HEMOVAC TM VENTED WOUND KIT (K800577)Snyder Laboratories, Inc.1980-04-16
SNYDER HYSTERECTOMY Y TUBE KIT (K800543)Snyder Laboratories, Inc.1980-04-16
SURGIVAC TM (K800578)Snyder Laboratories, Inc.1980-04-16
TLS TM SURGICAL DRAINAGE SYSTEM (K800581)Glasrock Products, Inc.1980-04-04
100 ML SNYDER HEMOVAC (K800542)Snyder Laboratories, Inc.1980-04-02
SURGITEK FOERSTER FACE LIFT DRAIN (K800331)Medical Engineering Corp.1980-03-05
DAVOL/ABAMSON SILICONE SUMP DRAIN (K800081)Davol, Inc.1980-01-28
DOW CORNING/W RIGHT WOUND DRAINAGE SYS (K800014)Dow Corning Corp. Healthcare Industries Materials1980-01-17
CLOSED WOUND VACUUM DRAINAGE SYSTEM (K790654)3M Company1979-04-26
MAXI-VAC TM (K790763)Med General1979-04-23
ASTRA-VAC (K782115)Ab Astra1979-02-01
ROUND SILICONE DRAIN (K782028)Davol, Inc.1978-12-20
FLAT SILICONE DRAIN (K782026)Davol, Inc.1978-12-12
HEMOVAC TUBING MATERIAL CHANGE (K781400)Snyder Laboratories, Inc.1978-09-20
PORTABLE CLOSED WOUND SUCTION EVACUATOR (K780848)Biomet, Inc.1978-08-23
VYGON RED-O-PACK (K771015)Coastal Bend Medical Products, Inc.1977-07-11
T-TUBE DRAIN, ROUND (K760778)Heyer Schulte Corp.1976-11-03
SILASTIC BRAND G7-2090A (K760700)Dow Corning Corp. Healthcare Industries Materials1976-11-02
YASARGIL SUCTION TUBE - SMALL (K760745)Codman & Shurtleff, Inc.1976-11-01
YASARGIL SUCTION TUBE - LARGE (K760746)Codman & Shurtleff, Inc.1976-11-01
ARGYLE SUCTION CONTROL KIT (K760601)Sherwood Medical Co.1976-11-01
YASARGIL SUCTION TUBE - MEDIUM (K760747)Codman & Shurtleff, Inc.1976-11-01
SPONGE, RICHARDS WOUND DRAINAGE SYSTEM (K760257)Richard'S Medical Equip., Inc.1976-08-09

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