Atlas FDA

KOE

27 FDA 510(k) clearances · Product code

85 daysmedian time to decision
265 days90th percentile
27clearances measured

FDA profile

Official device name
Dilator, Urethral
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5520
Medical specialty
Gastroenterology, Urology
Adverse events (MAUDE)
2019: 20 · 2020: 23 · 2021: 19 · 2022: 15 · 2023: 20 · 2024: 22
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
Optilume Basic Urological Balloon Dilation Catheter (K191061)Urotronic, Inc.2020-01-02
ATRION MEDICAL QL INFLATION DEVICE (K032840)Atrion Medical Products, Inc.2004-03-03
ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE (K972964)Atrion Medical Products, Inc.1997-10-10
BARD EAGLE INFLATION DEVICE (K962611)Ryder Intl. Corp.1996-10-21
AQ HYDROPHILIC DILATORS (K961904)Cook Urological, Inc.1996-10-18
U.S. MEDICAL PS-7000 DIALYSIS SCALE (K924440)U.S. Medical Corp.1993-05-26
120 FR OPTILUME PROSTATE BALLOON DILATOR (K920551)American Medical Systems, Inc.1992-10-28
DOWD(TM) II (K922349)Boston Scientific Corp1992-08-14
ENTRAC URETHRAL BALLOON DILATATION CATHETER (K920711)American Medical Systems, Inc.1992-05-06
APEX(TM) PROSTATIC BALLOON DILATION CATHETER (K913477)Peripheral Systems Group1991-12-27
UROPLASTY TCU PROSTATIC URETHROPLASTY CATHETER (K902585)Advanced Surgical Intervention, Inc.1990-08-27
ASI TCU PROSTATIC URETHROPLASTY CATHETER & ACCESS. (K896713)Advanced Surgical Intervention, Inc.1990-05-24
AMS OPTILUME INFLATION SYRINGE (K900760)American Medical Systems, Inc.1990-05-17
AMS OPTILUME(TM) PROSTATE BALLOON DILATOR (K900761)American Medical Systems, Inc.1990-05-17
URETHRAL BALLOON DILATION CATHETER SET (K892855)Cook Urological, Inc.1989-11-17
PROSTATIC URETHRO. BALLOON DILATATION CATHETER (K873295)Medi-Tech, Inc.1989-07-31
DEVINE (SUPRAPUBIC SOUND AND GUIDE) (K873177)Penn Medical Devices, Inc.1987-10-14
VAN-TEC URETHRAL DILATATION SYSTEM (K870695)Van-Tec, Inc.1987-03-10
VAN-TEC MEATAL DILATOR (K851158)Van-Tec, Inc.1985-04-15
KOLLMANN URETHRAL DILATOR (K841386)Imm Enterprises , Ltd.1984-05-09
URETERAL DILATOR (K840746)American Edwards Laboratories1984-04-13
VNACE FASCIAL DILATOR SET (K811833)Vance Products, Inc.1981-07-10
VANCE URETHAL DILATOR SET (K810371)Vance Products, Inc.1981-03-20
BOUGIE A BOULE (K800611)G.D. Searle and Co.1980-04-08
URETHRAL SOUND (K800610)G.D. Searle and Co.1980-04-08
VANCE PHILIPS FOLLOWER CATHETER & BOUGIE (K792221)Vance Products, Inc.1979-12-06
VANCE MALLEABLE TIP FILIFORM (K792219)Vance Products, Inc.1979-12-06

Track KOE automatically

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