Enseal G2 Articulating Tissue Sealers, Straight Jaw, Enseal G2 Articulating Tissue Sealers, Curved Jaw
FDA 510(k) K122797 · Ethicon Endo-Surgery, LLC
510(k) numberK122797
Submission
- Device name
- Enseal G2 Articulating Tissue Sealers, Straight Jaw, Enseal G2 Articulating Tissue Sealers, Curved Jaw
- Applicant
- Ethicon Endo-Surgery, LLC
Cincinnati, OH, US - Received
- September 12, 2012
- Decision date
- January 25, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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Questions and answers
When was Enseal G2 Articulating Tissue Sealers, Straight Jaw, Enseal G2 Articulating Tissue Sealers, Curved Jaw cleared by the FDA?
Enseal G2 Articulating Tissue Sealers, Straight Jaw, Enseal G2 Articulating Tissue Sealers, Curved Jaw (K122797) received a 510(k) decision of Substantially Equivalent on January 25, 2013, 135 days after the submission was received.
What is the product code of K122797?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.