510(k) K123212
- Device
- ETHICON ENDO-SURGERY ENSEAL G2 CORDLESS TISSUE SEALERS
- Applicant
- ETHICON ENDO-SURGERY, LLC
- 510(k) number
- K123212
- Product code
- PDG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-03-08
- Date received
- 2012-10-15
- Regulation
- 878.4400
- Classification name
- Electrosurgical Vessel And/or Tissue Sealer. With Built-in Generator.
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LIPING WU
- Address
- 4545 Creek Rd. Cincinnati OH US 45242 45242
Source Documents#
Legacy Summary#
summary
FDA Review#
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