ENSEAL G2 TISSUS SEALERS
FDA 510(k) clearance K112033 · decided 2011-11-08
Clearance details
- K-number
- K112033
- Device name
- ENSEAL G2 TISSUS SEALERS
- Applicant
- Ethicon Endo-Sugery, LLC
- Decision
- Substantially Equivalent
- Date received
- 2011-07-15
- Decision date
- 2011-11-08
- Days to decision
- 116 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
- Cincinnati, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Ethicon Endo-Surgery Inc. The ENSEAL G2 Tissue Sealers are indicated for bipolar coagulati recall (Z-0758-2013) | Ethicon Endo-Surgery Inc | 2013-01-31 |
| ENSEAL 5 mm Diameter Tissue Sealer G2 14 cm Length Curved Jaw, Model # NSLG2C14 and ENSEAL recall (Z-1244-2012) | Ethicon Endo-Surgery Inc | 2012-03-21 |
| ENSEAL Laparoscopic 5 mm Diameter Tissue Sealer G2 35 cm Length Curved Jaw, Model # NSLG2C recall (Z-1245-2012) | Ethicon Endo-Surgery Inc | 2012-03-21 |
| ENSEAL 5 mm Diameter Tissue Sealer G2 14 cm Length Straight Jaw, Model # NSLG2S14 and ENSE recall (Z-1246-2012) | Ethicon Endo-Surgery Inc | 2012-03-21 |
| ENSEAL Laparoscopic 5 mm Diameter Tissue Sealer G2 35 cm Length Straight Jaw, Model # NSLG recall (Z-1247-2012) | Ethicon Endo-Surgery Inc | 2012-03-21 |