KOE — Dilator, Urethral Class II
FDA product code KOE covers "Dilator, Urethral", a Class II medical device regulated under 21 CFR 876.5520. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KOE
- Device Class
- Class II
- Regulation Number
- 876.5520
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K191061 | urotronic | Optilume Basic Urological Balloon Dilation Catheter | January 2, 2020 |
| K032840 | atrion medical products | ATRION MEDICAL QL INFLATION DEVICE | March 3, 2004 |
| K972964 | atrion medical products | ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE | October 10, 1997 |
| K962611 | ryder intl | BARD EAGLE INFLATION DEVICE | October 21, 1996 |
| K961904 | cook urological | AQ HYDROPHILIC DILATORS | October 18, 1996 |
| K924440 | u.s. medical | U.S. MEDICAL PS-7000 DIALYSIS SCALE | May 26, 1993 |
| K920551 | american medical systems | 120 FR OPTILUME PROSTATE BALLOON DILATOR | October 28, 1992 |
| K922349 | boston scientific | DOWD(TM) II | August 14, 1992 |
| K920711 | american medical systems | ENTRAC URETHRAL BALLOON DILATATION CATHETER | May 6, 1992 |
| K913477 | peripheral systems group | APEX(TM) PROSTATIC BALLOON DILATION CATHETER | December 27, 1991 |
| K902585 | advanced surgical intervention | UROPLASTY TCU PROSTATIC URETHROPLASTY CATHETER | August 27, 1990 |
| K896713 | advanced surgical intervention | ASI TCU PROSTATIC URETHROPLASTY CATHETER & ACCESS. | May 24, 1990 |
| K900761 | american medical systems | AMS OPTILUME(TM) PROSTATE BALLOON DILATOR | May 17, 1990 |
| K900760 | american medical systems | AMS OPTILUME INFLATION SYRINGE | May 17, 1990 |
| K892855 | cook urological | URETHRAL BALLOON DILATION CATHETER SET | November 17, 1989 |
| K873295 | medi-tech | PROSTATIC URETHRO. BALLOON DILATATION CATHETER | July 31, 1989 |
| K873177 | penn medical devices | DEVINE (SUPRAPUBIC SOUND AND GUIDE) | October 14, 1987 |
| K870695 | van-tec | VAN-TEC URETHRAL DILATATION SYSTEM | March 10, 1987 |
| K851158 | van-tec | VAN-TEC MEATAL DILATOR | April 15, 1985 |
| K841386 | imm enterprises | KOLLMANN URETHRAL DILATOR | May 9, 1984 |