Product code KOE
- Device name
- Dilator, Urethral
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5520
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K191061 | Optilume Basic Urological Balloon Dilation Catheter | Urotronic, Inc. | 2020-01-02 |
| K032840 | ATRION MEDICAL QL INFLATION DEVICE | Atrion Medical Products, Inc. | 2004-03-03 |
| K972964 | ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE | Atrion Medical Products, Inc. | 1997-10-10 |
| K962611 | BARD EAGLE INFLATION DEVICE | Ryder Intl. Corp. | 1996-10-21 |
| K961904 | AQ HYDROPHILIC DILATORS | Cook Urological, Inc. | 1996-10-18 |
| K924440 | U.S. MEDICAL PS-7000 DIALYSIS SCALE | U.S. Medical Corp. | 1993-05-26 |
| K920551 | 120 FR OPTILUME PROSTATE BALLOON DILATOR | American Medical Systems, Inc. | 1992-10-28 |
| K922349 | DOWD(TM) II | Boston Scientific Corp | 1992-08-14 |
| K920711 | ENTRAC URETHRAL BALLOON DILATATION CATHETER | American Medical Systems, Inc. | 1992-05-06 |
| K913477 | APEX(TM) PROSTATIC BALLOON DILATION CATHETER | Peripheral Systems Group | 1991-12-27 |
| K902585 | UROPLASTY TCU PROSTATIC URETHROPLASTY CATHETER | Advanced Surgical Intervention, Inc. | 1990-08-27 |
| K896713 | ASI TCU PROSTATIC URETHROPLASTY CATHETER & ACCESS. | Advanced Surgical Intervention, Inc. | 1990-05-24 |
| K900760 | AMS OPTILUME INFLATION SYRINGE | American Medical Systems, Inc. | 1990-05-17 |
| K900761 | AMS OPTILUME(TM) PROSTATE BALLOON DILATOR | American Medical Systems, Inc. | 1990-05-17 |
| K892855 | URETHRAL BALLOON DILATION CATHETER SET | Cook Urological, Inc. | 1989-11-17 |
| K873295 | PROSTATIC URETHRO. BALLOON DILATATION CATHETER | Medi-Tech, Inc. | 1989-07-31 |
| K873177 | DEVINE (SUPRAPUBIC SOUND AND GUIDE) | Penn Medical Devices, Inc. | 1987-10-14 |
| K870695 | VAN-TEC URETHRAL DILATATION SYSTEM | Van-Tec, Inc. | 1987-03-10 |
| K851158 | VAN-TEC MEATAL DILATOR | Van-Tec, Inc. | 1985-04-15 |
| K841386 | KOLLMANN URETHRAL DILATOR | Imm Enterprises , Ltd. | 1984-05-09 |
| K840746 | URETERAL DILATOR | American Edwards Laboratories | 1984-04-13 |
| K811833 | VNACE FASCIAL DILATOR SET | Vance Products, Inc. | 1981-07-10 |
| K810371 | VANCE URETHAL DILATOR SET | Vance Products, Inc. | 1981-03-20 |
| K800610 | URETHRAL SOUND | G.D. Searle and Co. | 1980-04-08 |
| K800611 | BOUGIE A BOULE | G.D. Searle and Co. | 1980-04-08 |
| K792221 | VANCE PHILIPS FOLLOWER CATHETER & BOUGIE | Vance Products, Inc. | 1979-12-06 |
| K792219 | VANCE MALLEABLE TIP FILIFORM | Vance Products, Inc. | 1979-12-06 |
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| 08714729341376 | UroMax Ultra Kit | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729341369 | UroMax Ultra Kit | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729341352 | UroMax Ultra Kit | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729341345 | UroMax Ultra Kit | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729341338 | UroMax Ultra Kit | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729341321 | UroMax Ultra Kit | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729341314 | UroMax Ultra Kit | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729341307 | UroMax Ultra Kit | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729341291 | UroMax Ultra Kit | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729341284 | UroMax Ultra Kit | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729341277 | UroMax Ultra Kit | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729341260 | UroMax Ultra | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729341253 | UroMax Ultra | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729341246 | UroMax Ultra | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729302421 | UroMax Ultra Kit | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729341222 | UroMax Ultra | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729341208 | UroMax Ultra | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729341192 | UroMax Ultra | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729341185 | UroMax Ultra | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729341178 | UroMax Ultra | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729341161 | UroMax Ultra | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729341154 | UroMax Ultra | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729341147 | UroMax Ultra | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729341130 | UroMax Ultra | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729341123 | UroMax Ultra | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729341116 | UroMax Ultra | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729341109 | UroMax Ultra | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729302445 | UroMax Ultra Kit | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |
| 08714729302438 | UroMax Ultra Kit | BOSTON SCIENTIFIC CORPORATION | 2016-09-24 |