Atlas FDA

GEA

36 FDA 510(k) clearances · Product code

62 daysmedian time to decision
133 days90th percentile
36clearances measured

FDA profile

Official device name
Cannula, Surgical, General & Plastic Surgery
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Medical specialty
General, Plastic Surgery
Adverse events (MAUDE)
2021: 149 · 2022: 83 · 2023: 74 · 2024: 98 · 2025: 71 · 2026: 27
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
MRI SAFE INSTRUMENTS (K003965)Aesculap, Inc.2001-03-16
GENICON TROCAR (K982472)Genicon, LC1999-02-04
CONMED TROGARD ELECTRONIC TROCAR SYSTEM (K954599)Conmedcorp1995-11-27
ORIGIN SECONDARY CANNULA AND TROCAR (K922460)Origin Medsystems, Inc.1992-09-16
ENDOPATH DISPOSABLE THORACIC TROCAR SLEEVE (K920110)ETHICON, Inc.1992-04-02
DISPOSABLE SPECIMEN BAG W/CANNULA AND INTRODUCER (K911262)ETHICON, Inc.1991-06-20
DISPOSABLE YANKAUER SUCTION TUBE (K904881)Pilling Medical S.A.1991-03-06
CANNULA, SURGICAL (K903416)Advantage Diagnostics Corp.1990-11-23
SUCTION SYSTEM (K904218)Axiom Medical, Inc.1990-10-31
KLEIN MICRO-CANNULA(TM) (K901717)Jeff Klein Surgical, Inc.1990-05-24
KLEIN LAMPREY-CANNULA(TM) (K901718)Jeff Klein Surgical, Inc.1990-05-24
KLEIN MICRO-CANNULA HANDLE(TM) (K901719)Jeff Klein Surgical, Inc.1990-05-22
SOFT SUCTION ADAPTER (K895684)Applied Medical Technologies1989-11-20
AUTO SUTURE SURGIPORT CANNULA DIAMETER REDUCER* (K896434)United States Surgical, A Division of Tyco Healthc1989-11-16
CANULA SUCTION FOR SURGICAL GENERAL AND PLASTIC (K895762)Kolster Methods1989-10-18
SURGICAL SUCTION APPARATUS (K895670)Baker-Sundt Research, Inc.1989-09-27
L-5 PLASTIC SURGERY CANNULAS (K880669)American Instrument Manufacturer'S, Inc.1988-03-17
COOPER SURG ASPIRATION CANNULA/CUSTOM CONVEN PAKS (K872214)CooperVision, Inc.1987-08-17
SUCTION TUBE TIP FITS OVER BUSSIE FRAZIER TUBE (K872906)American Silk Sutures, Inc.1987-08-11
APEX SUCTION CURETTE (K871384)Apex Medical, Inc.1987-05-22
(I) LV AND (II) HV SERIES CANNULA (K871043)Celebration Medical Products, Inc.1987-04-23
DISPOSABLE SUCTION CANNULA NO. 902008-000 (K863293)Lifestream Int'L, Inc.1986-09-09
BOWEN CANNULA (K863150)Bowen & Company, Inc.1986-09-05
NEWMAN CANNULAE SYSTEM (NCS) (K862936)Byron Medical1986-08-14
SUCTION SYSTEM (K861306)Axiom Medical, Inc.1986-06-09
DEDO SUCTION CANNULA (K854005)Dedo Manufacturer, Inc.1985-12-06
PENNINE LINK YANKAUERS (K844874)Pennine Medical , Ltd.1985-06-06
PHARMA-PLAST SUCTION SET TYPE YANKAUER (K843468)Zimmar Consulting , Ltd.1984-11-23
CANNULA (K843187)ETHICON, Inc.1984-10-31
MEDICALEX (K833377)Medicalex1984-09-27
SUCTION CANNULAS (K841249)Custom Surgical Products, Inc.1984-06-04
PADGETT SUCTION CANNULA (K833717)Advanced Biosearch Assn.1983-12-14
PLASTIC SUCTION TIPS (K832521)Wells Johnson Co.1983-10-20
SUCTION TIPS (K832520)Wells Johnson Co.1983-10-20
FRAZIER SUCTION INSTRUMENT-DISPOS (K832636)Pilling Co.1983-10-14
MODEL 1301 BIOTAC (TM) (K810627)Progress Mankind Technology1981-04-02

Track GEA automatically

Every clearance here is in the API, with alerts when new ones post.