KOE — Dilator, Urethral Class II
FDA Device Classification
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 |