Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick Bipolar Irrigating forceps, Single Use Non-Stick Bipolar Suction forceps
FDA 510(k) clearance K182773 · decided 2019-10-08
Clearance details
- K-number
- K182773
- Device name
- Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick Bipolar Irrigating forceps, Single Use Non-Stick Bipolar Suction forceps
- Applicant
- Faulhaber Pinzetten Ohg
- Decision
- Substantially Equivalent
- Date received
- 2018-10-01
- Decision date
- 2019-10-08
- Days to decision
- 372 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
- Frittlingen, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.