AQUAMANTYS 3 PUMP GENERATOR, BIPOLAR SEALER, BIPOLAR SEALER WITH CUTTING
FDA 510(k) clearance K111285 · decided 2011-09-09
Clearance details
- K-number
- K111285
- Device name
- AQUAMANTYS 3 PUMP GENERATOR, BIPOLAR SEALER, BIPOLAR SEALER WITH CUTTING
- Applicant
- Salient Surgical Technologies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-05-06
- Decision date
- 2011-09-09
- Days to decision
- 126 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
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Salient Surgical Technologies
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 |
|---|---|---|
| Medtronic Advanced Energy Aquamantys3 Pump Generator; Product Catalog Number: 10-1357 (Gen recall (Z-0905-2014) | Medtronic Advanced Energy, LLC | 2014-01-31 |