510(k) K900761
- Device
- AMS OPTILUME(TM) PROSTATE BALLOON DILATOR
- Applicant
- AMERICAN MEDICAL SYSTEMS, INC.
- 510(k) number
- K900761
- Product code
- KOE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-05-17
- Date received
- 1990-02-16
- Regulation
- 876.5520
- Classification name
- Dilator, Urethral
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DENNIS TOUSSAINT
- Address
- 11001 Bren Rd. E. Minnetonka MN US 55343 55343
FDA Registration Numbers#
- 1018470
- 1037955
- 3043337628
- 2183744
- 9611102
- 3006546082
- 3013530345
- 1313046
- 3012322232
- 1060680
- 1923569
- 3030733800
- 3006554912
- 1043214
- 3013497507
- 3005580113
- 3030516433
- 3004730544
- 9617744
- 3010273872
- 1058020
- 3010400865
- 3003790304
- 2124215
- 9611590
- 3005099803
- 3002807314
- 3030446844
- 1055236
- 2431166
- 3002647932
- 1625425
- 1720747
- 3005987240
- 1000121056
- 1825146
- 3014579161
- 9617592
- 3010011359
- 3010707607
- 1644312
- 8044098
- 3011050570
- 3021023752
- 1000393132
- 3003882387
- 3015228875
- 9610617
- 3010202439
- 1047843
- 2020550
- 1646831
- 3015895045
- 1820334
- 1647149
- 3014342096
- 3013460719
- 3035480112
- 9710641
- 3006082230
- 1018233
- 3013557562
- 1043729
- 9610621
- 1054241
- 9681260
- 1928237
- 1225687
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KOE #
| 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 |
| K892855 | URETHRAL BALLOON DILATION CATHETER SET | Cook Urological, Inc. | 1989-11-17 |
| K873295 | PROSTATIC URETHRO. BALLOON DILATATION CATHETER | Medi-Tech, Inc. | 1989-07-31 |
Legacy Summary#
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FDA Review#
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