510(k) K112033 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
ENSEAL G2 TISSUS SEALERS
| Applicant | Ethicon Endo-Sugery, LLC, Cincinnati OH, US |
| Decision | Substantially Equivalent, Nov 8, 2011 |
| Received | Jul 15, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112033
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 31, 2013 | Ethicon Endo-Surgery Inc Ethicon Endo-Surgery Inc. The ENSEAL G2 Tissue Sealers are indicated for bipolar coagulation and mechanical transection of tissue during laparoscopic and open procedures.
Model Numbers:
NSLG2C14 Terminated |
GEI | None listed |
| Mar 21, 2012 | Ethicon Endo-Surgery Inc ENSEAL 5 mm Diameter Tissue Sealer G2 14 cm Length Curved Jaw, Model # NSLG2C14 and ENSEAL 5 mm Diameter Tissue Sealer G2 25 cm Length Curved Jaw, Model # NSLG2C25. Ethicon Endo-Surgery, LLC Guaynabo Terminated |
GEI | None listed |
| Mar 21, 2012 | Ethicon Endo-Surgery Inc ENSEAL Laparoscopic 5 mm Diameter Tissue Sealer G2 35 cm Length Curved Jaw, Model # NSLG2C35 and ENSEAL Laparoscopic 5 mm Diameter Tissue Sealer G2 45 cm Length Curved Jaw, Model # NSLG2C45. Ethicon Terminated |
LFL | None listed |
| Mar 21, 2012 | Ethicon Endo-Surgery Inc ENSEAL 5 mm Diameter Tissue Sealer G2 14 cm Length Straight Jaw, Model # NSLG2S14 and ENSEAL 5 mm Diameter Tissue Sealer G2 25 cm Length Straight Jaw, Model # NSLG2S25. Ethicon Endo-Surgery, LLC Guay Terminated |
LFL | None listed |
| Mar 21, 2012 | Ethicon Endo-Surgery Inc ENSEAL Laparoscopic 5 mm Diameter Tissue Sealer G2 35 cm Length Straight Jaw, Model # NSLG2S35. Ethicon Endo-Surgery, LLC Guaynabo, Puerto Rico 00969
The ENSEAL G2 Tissue Sealers are indicated for b Terminated |
LFL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.