Atlas FDA

KOA

44 FDA 510(k) clearances · Product code

43 daysmedian time to decision
185 days90th percentile
44clearances measured

FDA profile

Official device name
Surgical Instruments, G-U, Manual (And Accessories)
Device class
Class I (low risk)
Regulation
21 CFR 876.4730
Medical specialty
Gastroenterology, Urology
Adverse events (MAUDE)
1994: 1 · 1995: 1 · 1997: 2 · 1998: 1 · 2001: 3 · 2002: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
FiXcision (K182664)Agency For Medical Innovations GmbH2018-12-07
URETHRAL SUTURE GUIDE (K950267)Applied Medical Resources1995-01-31
LI VASECTOMY (K932465)Femcare , Ltd.1994-03-02
VASOVASOSTOMY SET (K921546)Cook Urological, Inc.1993-07-02
VESITEC SUTURE PASSER (K931181)Vesitec Medical, Inc.1993-05-12
DDV LIGATOR (K921304)North American Medical, Inc.1992-10-05
NO-SCALPEL VASCETOMY INSTRUMENTS (K922971)Pilling Co.1992-09-23
BENDEREV PROTECT-A-PASS NEEDLE (K921228)Eimark Labs, Inc.1992-09-14
VAS DILATOR (K922192)Cook Urological, Inc.1992-08-07
GRASPING FORCEPS (K896058)Annex Medical, Inc.1989-12-28
MARLOW ANAL SPECULUM (K891352)Simpson/Basye, Inc.1989-06-23
MICROSURGICAL CYSTOTOME (K890218)Kinetic Medical Products1989-01-27
STOMACH EVACULATOR - EWALD STYLE (K864963)Medovations, Inc.1987-10-14
MARTIN MEDICAL PRO-SCOPE ANOSCOPE (K863273)Martin Medical1986-11-04
EFFNER SIMS RECTAL SPECULUM W/FIBER OPTIC ILLUMINA (K852014)Effner and Spreine Co.1985-08-07
BABCOCK TISSUE FORCEPS, 6-1/4 + SS 410 OR 420 (K852725)The Huxley Instrument Corp.1985-07-09
ALLIS TISSUE FORCEPS, 4X5 TEETH, 6+SS 410 OR 420 (K852726)The Huxley Instrument Corp.1985-07-09
AL ASKARI PERCUTANEOUS ACCESS NEEDLE HOLDER (K851162)Van-Tec, Inc.1985-04-15
RANDALL KIDNEY STONE FORCEPS 817-144 PCS. QUARTER (K851112)The Huxley Instrument Corp.1985-04-03
RANDALL KIDNEY STONE FORCEPS 817-144 PCS. FULL CUR (K851113)The Huxley Instrument Corp.1985-04-03
RANDALL KIDNEY STONE FORCEPS 817-84 PCS. HALF CURV (K851111)The Huxley Instrument Corp.1985-04-03
WESTON RECTAL SNARE (K841387)Imm Enterprises , Ltd.1984-05-09
OP-CON SURG. INSTRUMENT #3 (K834171)Imm Enterprises , Ltd.1984-04-04
JAKOBI SURGICAL INSTRUMENTS #3 17/18/19 (K834191)Imm Enterprises , Ltd.1984-03-22
JAKOBI SURG. INSTRUMENTS #3 21/22/24 (K834192)Imm Enterprises , Ltd.1984-03-22
PROBES, VARIOUS (K841003)Premier Dental Products Co.1984-03-20
P-S MEDICAL BERLIN VISADUCT KIT (K832677)Pudenz-Schulte Medical Research Corp.1983-12-08
DISIMETRIC RELEASE OF INSTRANETICS RAD (K830786)American Convertors Div., American Pharmaseal1983-05-18
ST. MARK'S RECTAL BIOPSY FORCEPS (K822401)Keymed, Inc.1982-08-27
URETHAL CUTTER CLAMP (K820015)Lone Star Medical Products, Inc.1982-02-22
ACESSORY TO MODIFIED FREEDING JEJUNOSTO (K813504)Midwest Metabolic Support Group1982-01-07
FORDER RETRACTOR (K811973)Surgemed Marketing, Inc.1981-07-31
FORDER RETRACTOR (K811693)Dacomed Corp.1981-06-26
VASOVASOSTOMY STABILIZER PLATFORM DEV (K811223)Biomet, Inc.1981-05-21
THE SCOTT DIALMENZENSERT (K810915)Lone Star Medical Products, Inc.1981-05-08
CIRCLE NEPHROSTOMY TUBE INTRODUCER (K810533)American V. Mueller1981-03-11
THE INQUINAL RESORVOIR INSERTER (K802983)Lone Star Medical Products, Inc.1980-12-30
MAGILL CATHETER INTRO. FORCEPS (K801273)J. Sklar Mfg. Co., Inc.1980-07-28
RUDD-CLINIC HEMORRHOIDAL FORCEPS (K800441)J. Sklar Mfg. Co., Inc.1980-04-08
SYRINGE, IRRIGATION, PRE-FILLED (K772134)Kendall Research Center1977-11-28
ANAL/RECTAL SYRINGE (K761229)Ace Orthopedic Manufacturing Co.1977-02-24
FLEXIBLE CUTTING SCISSORS (K760715)V. Mueller O.V. Baxter Healthcare Corp.1976-10-21
FLEXIBLE BIOPSY FORCEPS (K760717)V. Mueller O.V. Baxter Healthcare Corp.1976-10-21
FLEXIBLE FOREIGN BODY FORCEPS (K760716)V. Mueller O.V. Baxter Healthcare Corp.1976-10-15

Track KOA automatically

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