FDA product code PDG: Electrosurgical Vessel And/Or Tissue Sealer. With Built-In Generator.
PDG is the FDA product code for electrosurgical vessel and/or tissue sealer. with built-in generator.. It is a Class II device, regulated under 21 CFR 878.4400 and reviewed by the General and Plastic Surgery panel. FDA has cleared 1 510(k) submission under PDG. The average 510(k) review took 144 days (median 144).
Definition
Intended for any procedure where vessel ligation (cutting and sealing), soft tissue grasping and dissection are performed.
Classification
| Field | Value |
|---|---|
| Device name | Electrosurgical Vessel And/Or Tissue Sealer. With Built-In Generator. |
| Device class | Class II |
| Regulation | 21 CFR 878.4400 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every PDG clearance
Top PDG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ethicon Endo-Surgery, LLC | 1 | 2013-03-08 |
Most recent PDG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K123212 | Ethicon Endo-Surgery, LLC | ETHICON ENDO-SURGERY ENSEAL G2 CORDLESS TISSUE SEALERS | 2013-03-08 | 144 |
Recalls for PDG devices
openFDA lists no recalls for product code PDG.
Frequently asked questions
What is FDA product code PDG?
PDG is the FDA product code for electrosurgical vessel and/or tissue sealer. with built-in generator.. It is a Class II device, regulated under 21 CFR 878.4400 and reviewed by the General and Plastic Surgery panel.
What device class is PDG?
Class II, regulation 21 CFR 878.4400. Typical premarket route: 510(k).
How long does a 510(k) take for product code PDG?
Across 1 cleared submissions the average was 144 days from receipt to decision (median 144).
Which companies have the most PDG clearances?
Ethicon Endo-Surgery, LLC (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PDG
- Run a recall and safety report across every PDG manufacturer
- Watch product code PDG for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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