PDG — Electrosurgical Vessel And/Or Tissue Sealer. With Built-In Generator. Class II
FDA product code PDG covers "Electrosurgical Vessel And/Or Tissue Sealer. With Built-In Generator.", a Class II medical device regulated under 21 CFR 878.4400. Submissions are reviewed by the General, Plastic Surgery panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- PDG
- Device Class
- Class II
- Regulation Number
- 878.4400
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Definition
Intended for any procedure where vessel ligation (cutting and sealing), soft tissue grasping and dissection are performed.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K123212 | ethicon endo-surgery | ETHICON ENDO-SURGERY ENSEAL G2 CORDLESS TISSUE SEALERS | March 8, 2013 |