STINGRAY ELECTROSURGICAL FORCEPS
FDA 510(k) clearance K083162 · decided 2009-01-12
Clearance details
- K-number
- K083162
- Device name
- STINGRAY ELECTROSURGICAL FORCEPS
- Applicant
- Stingray Surgical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-10-27
- Decision date
- 2009-01-12
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Deer Field, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Bipolar Forceps model number: S02-XXX, S03-XXX, P02-XXX, and P03-XXX. "Instructions For Us recall (Z-2011-2012) | Stingray Surgical Products, LLC | 2012-07-13 |