PDGClass II
Electrosurgical Vessel And/Or Tissue Sealer. With Built-In Generator.
21 CFR 878.4400 / General, Plastic Surgery
PDG is the FDA product code for Electrosurgical Vessel And/Or Tissue Sealer. With Built-In Generator., a class II device type, regulated under 21 CFR 878.4400. FDA's definition for this code reads: "Intended for any procedure where vessel ligation (cutting and sealing), soft tissue grasping and dissection are performed". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- PDG
- Device name
- Electrosurgical Vessel And/Or Tissue Sealer. With Built-In Generator.
- FDA definition
- Intended for any procedure where vessel ligation (cutting and sealing), soft tissue grasping and dissection are performed.
- Regulation
- 21 CFR 878.4400
- Device class
- Class II
- Review panel
- General, Plastic Surgery
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code PDG
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2013 | 1 |
Applicants with the most clearances
Product code PDG| Applicant | Clearances |
|---|---|
| Ethicon Endo-Surgery Inc | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code PDG.
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