AMS MALE TRANSOBTURATOR SLING SYSTEM
FDA 510(k) clearance K053371 · decided 2006-02-03
Clearance details
- K-number
- K053371
- Device name
- AMS MALE TRANSOBTURATOR SLING SYSTEM
- Applicant
- American Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-12-05
- Decision date
- 2006-02-03
- Days to decision
- 60 days
- Clearance type
- Traditional
- Product code
- OTM
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Minnetonka, MN, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
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| VIRTURE MALE SLING SYSTEM WITH ALEXIS WOUND RETRACTOR CONVENIENCE KIT (K113496) | Coloplast A/S | 2012-02-14 |
| VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT (K111881) | Coloplast A/S | 2011-08-17 |
| VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM MODEL 50020 (K101297) | Coloplast A/S | 2010-06-03 |
| VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM, MODEL 50020 (K091152) | Coloplast A/S | 2009-05-07 |
| VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM (K082640) | Coloplast Manufacturing Us, LLC | 2008-10-17 |
| I-STOP TRANS OBTURATOR MALE SLING (K063079) | Cl Medical | 2006-11-07 |
| MALE REMEEX SYSTEM (K062341) | Specialities Remeex International, S.L. | 2006-11-02 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AdVance"Male Sling System, REF 720088-01 & AdVance" XP Male Sling System REF 720163-01 (no recall (Z-0806-2015) | American Medical Systems, Inc. | 2014-12-16 |
| AMS AdVance" Male Sling System 720088-01 AMS AdVance" Male Sling System (US) 720088-02 AMS recall (Z-0259-2013) | American Medical Systems, Inc. | 2012-11-07 |
| Model # 720088-01: AMS AdVance Male Sling System, US; Model # 720088-02: AMS AdVance Male recall (Z-0808-2011) | American Medical Systems, Inc. | 2010-12-27 |
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 |