ULTRALITE UROSYSTEM, MODELS GU-1 & GU-2
FDA 510(k) clearance K790519 · decided 1979-05-14
Clearance details
- K-number
- K790519
- Device name
- ULTRALITE UROSYSTEM, MODELS GU-1 & GU-2
- Applicant
- American Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-03-16
- Decision date
- 1979-05-14
- Days to decision
- 59 days
- Clearance type
- Traditional
- Product code
- FAP
- Device class
- 2
- Regulation number
- 876.1620
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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| URODYNAMIC CATHETERS (K923464) | R.L. Medical Corp. | 1993-02-05 |
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| 600 SERIES DYE MODULES (MODELS 630 AND 630 XP) AND SERIES 700 AND 800 KTP/532 AND KTP/YAG SURGICAL LASERS (P940012/S002) | American Medical Systems, Inc. | 1998-12-23 |
| 600 SERIES DYE MODULES (MODELS 630 AND 630 XP) AND SERIES 700 AND 800 KTP/532 AND KTP/YAG SURGICAL LASERS (P940012/S001) | American Medical Systems, Inc. | 1998-01-09 |
| 600 SERIES DYE MODULES (MODELS 630 AND 630 XP) AND SERIES 700 AND 800 KTP/532 AND KTP/YAG SURGICAL LASERS (P940012) | American Medical Systems, Inc. | 1995-12-27 |