FDA Product Code
FDA Product Code KOE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5520
510(k) Clearances — 27 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K191061 | Optilume Basic Urological Balloon Dilation Catheter | Urotronic, Inc. | 2020-01-02 | Traditional | PDF ↗ |
| K032840 | ATRION MEDICAL QL INFLATION DEVICE | Atrion Medical Products, Inc. | 2004-03-03 | Traditional | PDF ↗ |
| K972964 | ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE | Atrion Medical Products, Inc. | 1997-10-10 | Traditional | PDF ↗ |
| K962611 | BARD EAGLE INFLATION DEVICE | Ryder Intl. Corp. | 1996-10-21 | Traditional | PDF ↗ |
| K961904 | AQ HYDROPHILIC DILATORS | Cook Urological, Inc. | 1996-10-18 | Traditional | PDF ↗ |
| K924440 | U.S. MEDICAL PS-7000 DIALYSIS SCALE | U.S. Medical Corp. | 1993-05-26 | Traditional | PDF ↗ |
| K920551 | 120 FR OPTILUME PROSTATE BALLOON DILATOR | American Medical Systems, Inc. | 1992-10-28 | Traditional | PDF ↗ |
| K922349 | DOWD(TM) II | Boston Scientific Corp | 1992-08-14 | Traditional | PDF ↗ |
| K920711 | ENTRAC URETHRAL BALLOON DILATATION CATHETER | American Medical Systems, Inc. | 1992-05-06 | Traditional | PDF ↗ |
| K913477 | APEX(TM) PROSTATIC BALLOON DILATION CATHETER | Peripheral Systems Group | 1991-12-27 | Traditional | PDF ↗ |
| K902585 | UROPLASTY TCU PROSTATIC URETHROPLASTY CATHETER | Advanced Surgical Intervention, Inc. | 1990-08-27 | Traditional | PDF ↗ |
| K896713 | ASI TCU PROSTATIC URETHROPLASTY CATHETER & ACCESS. | Advanced Surgical Intervention, Inc. | 1990-05-24 | Traditional | PDF ↗ |
| K900761 | AMS OPTILUME(TM) PROSTATE BALLOON DILATOR | American Medical Systems, Inc. | 1990-05-17 | Traditional | PDF ↗ |
| K900760 | AMS OPTILUME INFLATION SYRINGE | American Medical Systems, Inc. | 1990-05-17 | Traditional | PDF ↗ |
| K892855 | URETHRAL BALLOON DILATION CATHETER SET | Cook Urological, Inc. | 1989-11-17 | Traditional | PDF ↗ |
| K873295 | PROSTATIC URETHRO. BALLOON DILATATION CATHETER | Medi-Tech, Inc. | 1989-07-31 | Traditional | PDF ↗ |
| K873177 | DEVINE (SUPRAPUBIC SOUND AND GUIDE) | Penn Medical Devices, Inc. | 1987-10-14 | Traditional | PDF ↗ |
| K870695 | VAN-TEC URETHRAL DILATATION SYSTEM | Van-Tec, Inc. | 1987-03-10 | Traditional | PDF ↗ |
| K851158 | VAN-TEC MEATAL DILATOR | Van-Tec, Inc. | 1985-04-15 | Traditional | PDF ↗ |
| K841386 | KOLLMANN URETHRAL DILATOR | Imm Enterprises , Ltd. | 1984-05-09 | Traditional | PDF ↗ |
| K840746 | URETERAL DILATOR | American Edwards Laboratories | 1984-04-13 | Traditional | PDF ↗ |
| K811833 | VNACE FASCIAL DILATOR SET | Vance Products, Inc. | 1981-07-10 | Traditional | PDF ↗ |
| K810371 | VANCE URETHAL DILATOR SET | Vance Products, Inc. | 1981-03-20 | Traditional | PDF ↗ |
| K800611 | BOUGIE A BOULE | G.D. Searle and Co. | 1980-04-08 | Traditional | PDF ↗ |
| K800610 | URETHRAL SOUND | G.D. Searle and Co. | 1980-04-08 | Traditional | PDF ↗ |
| K792219 | VANCE MALLEABLE TIP FILIFORM | Vance Products, Inc. | 1979-12-06 | Traditional | PDF ↗ |
| K792221 | VANCE PHILIPS FOLLOWER CATHETER & BOUGIE | Vance Products, Inc. | 1979-12-06 | Traditional | PDF ↗ |
Product code KOE · Class II · Gastroenterology, Urology. Data: openFDA.