AQUAMANTYS SS4.0 BIPOLAR SEALER, MODEL 23-121-1
FDA 510(k) clearance K063639 · decided 2007-02-22
Clearance details
- K-number
- K063639
- Device name
- AQUAMANTYS SS4.0 BIPOLAR SEALER, MODEL 23-121-1
- Applicant
- Tissuelink Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-12-07
- Decision date
- 2007-02-22
- 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
- Dover, NH, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Tissuelink Medical
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
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
No recalls on record reference this clearance.