Supra Non-Stick Bipolar Forceps
FDA 510(k) clearance K213042 · decided 2022-11-17
Clearance details
- K-number
- K213042
- Device name
- Supra Non-Stick Bipolar Forceps
- Applicant
- Guenter Bissinger Medizintechnik GmbH
- Decision
- Substantially Equivalent
- Date received
- 2021-09-22
- Decision date
- 2022-11-17
- Days to decision
- 421 days
- Clearance type
- Abbreviated
- Product code
- GEI
- Device class
- 2
- Regulation number
- 878.4400
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Teningen, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.