AQUAMANTYS DOUBLE CONE BIPOLAR SEALER MODEL: 23-310-1
FDA 510(k) clearance K101057 · decided 2011-04-05
Clearance details
- K-number
- K101057
- Device name
- AQUAMANTYS DOUBLE CONE BIPOLAR SEALER MODEL: 23-310-1
- Applicant
- Salient Surgical Technologies
- Decision
- Substantially Equivalent
- Date received
- 2010-04-15
- Decision date
- 2011-04-05
- Days to decision
- 355 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
- Portsmouth, NH, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.