Panels › Gastroenterology, Urology › Product code KOE · Class 2
Dilator, Urethral
Regulation 876.5520
0510(k)s in 12 months (27 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in KOE
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 2, 2020 | K191061 | Optilume Basic Urological Balloon Dilation Catheter Urotronic, Inc. | KOE |
| Mar 3, 2004 | K032840 | ATRION MEDICAL QL INFLATION DEVICE Atrion Medical Products, Inc. | KOE |
| Oct 10, 1997 | K972964 | ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE Atrion Medical Products, Inc. | KOE |
| Oct 21, 1996 | K962611 | BARD EAGLE INFLATION DEVICE Ryder Intl. Corp. | KOE |
| Oct 18, 1996 | K961904 | AQ HYDROPHILIC DILATORS Cook Urological, Inc. | KOE |
| May 26, 1993 | K924440 | U.S. MEDICAL PS-7000 DIALYSIS SCALE U.S. Medical Corp. | KOE |
| Oct 28, 1992 | K920551 | 120 FR OPTILUME PROSTATE BALLOON DILATOR American Medical Systems, Inc. | KOE |
| Aug 14, 1992 | K922349 | DOWD(TM) II Boston Scientific Corp | KOE |
| May 6, 1992 | K920711 | ENTRAC URETHRAL BALLOON DILATATION CATHETER American Medical Systems, Inc. | KOE |
| Dec 27, 1991 | K913477 | APEX(TM) PROSTATIC BALLOON DILATION CATHETER Peripheral Systems Group | KOE |
| Aug 27, 1990 | K902585 | UROPLASTY TCU PROSTATIC URETHROPLASTY CATHETER Advanced Surgical Intervention, Inc. | KOE |
| May 24, 1990 | K896713 | ASI TCU PROSTATIC URETHROPLASTY CATHETER & ACCESS. Advanced Surgical Intervention, Inc. | KOE |
| May 17, 1990 | K900761 | AMS OPTILUME(TM) PROSTATE BALLOON DILATOR American Medical Systems, Inc. | KOE |
| May 17, 1990 | K900760 | AMS OPTILUME INFLATION SYRINGE American Medical Systems, Inc. | KOE |
| Nov 17, 1989 | K892855 | URETHRAL BALLOON DILATION CATHETER SET Cook Urological, Inc. | KOE |
| Jul 31, 1989 | K873295 | PROSTATIC URETHRO. BALLOON DILATATION CATHETER Medi-Tech, Inc. | KOE |
| Oct 14, 1987 | K873177 | DEVINE (SUPRAPUBIC SOUND AND GUIDE) Penn Medical Devices, Inc. | KOE |
| Mar 10, 1987 | K870695 | VAN-TEC URETHRAL DILATATION SYSTEM Van-Tec, Inc. | KOE |
| Apr 15, 1985 | K851158 | VAN-TEC MEATAL DILATOR Van-Tec, Inc. | KOE |
| May 9, 1984 | K841386 | KOLLMANN URETHRAL DILATOR Imm Enterprises , Ltd. | KOE |
| Apr 13, 1984 | K840746 | URETERAL DILATOR American Edwards Laboratories | KOE |
| Jul 10, 1981 | K811833 | VNACE FASCIAL DILATOR SET Vance Products, Inc. | KOE |
| Mar 20, 1981 | K810371 | VANCE URETHAL DILATOR SET Vance Products, Inc. | KOE |
| Apr 8, 1980 | K800611 | BOUGIE A BOULE G.D. Searle and Co. | KOE |
| Apr 8, 1980 | K800610 | URETHRAL SOUND G.D. Searle and Co. | KOE |
| Dec 6, 1979 | K792221 | VANCE PHILIPS FOLLOWER CATHETER & BOUGIE Vance Products, Inc. | KOE |
| Dec 6, 1979 | K792219 | VANCE MALLEABLE TIP FILIFORM Vance Products, Inc. | KOE |
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