ETHICON ENDO-SURGERY ENSEAL G2 CORDLESS TISSUE SEALERS
FDA 510(k) clearance K123212 · decided 2013-03-08
Clearance details
- K-number
- K123212
- Device name
- ETHICON ENDO-SURGERY ENSEAL G2 CORDLESS TISSUE SEALERS
- Applicant
- Ethicon Endo-Surgery, LLC
- Decision
- Substantially Equivalent
- Date received
- 2012-10-15
- Decision date
- 2013-03-08
- Days to decision
- 144 days
- Clearance type
- Traditional
- Product code
- PDG
- 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
No recalls on record reference this clearance.