AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
FDA 510(k) clearance K082677 · decided 2008-12-23
Clearance details
- K-number
- K082677
- Device name
- AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
- Applicant
- American Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-09-15
- Decision date
- 2008-12-23
- Days to decision
- 99 days
- Clearance type
- Special
- Product code
- OTP
- Device class
- 3
- Regulation number
- 884.5980
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Minnetonka, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Elevate System with IntePro Lite", Anterior and Apical Prolapse Repair System, REF720093-0 recall (Z-2755-2011) | American Medical Systems, Inc. | 2011-07-07 |
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 |