GMD UNIVERSAL SLING, MODEL PRODUCT CODE 1010 AND 1020
FDA 510(k) clearance K083471 · decided 2009-03-03
Clearance details
- K-number
- K083471
- Device name
- GMD UNIVERSAL SLING, MODEL PRODUCT CODE 1010 AND 1020
- Applicant
- Generic Medical Device, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-11-24
- Decision date
- 2009-03-03
- Days to decision
- 99 days
- Clearance type
- Traditional
- Product code
- OTN
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Gig Harbor, WA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Generic Medical Device
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| The GMD UNIVERSAL URINARY INCONTINENCE SLING (Code 1010) is supplied sterile and is intend recall (Z-1390-2011) | Generic Medical Devices | 2011-02-22 |
| GMD UNIVERSAL URINARY INCONTINENCE SLING, Rx ONLY Product Code 1020-18. Intended for use i recall (Z-0268-2010) | Generic Medical Devices | 2009-11-16 |