TISSUELINK BIPOLAR FLOATING BALL DEVICE
FDA 510(k) clearance K020574 · decided 2002-05-20
Clearance details
- K-number
- K020574
- Device name
- TISSUELINK BIPOLAR FLOATING BALL DEVICE
- Applicant
- Tissuelink Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-02-21
- Decision date
- 2002-05-20
- Days to decision
- 88 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
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 |
|---|---|---|
| ADP2.1 Adapter, non-sterile reusable Model Number: 30-802-1 ,an accessory used with the Ti recall (Z-1415-04) | TissueLink Medical, Inc. | 2004-09-01 |
| ADP 3.2 Adapter, non sterile reusable Model Number: 30-801-1, an accessory used with the T recall (Z-1416-04) | TissueLink Medical, Inc. | 2004-09-01 |