510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K123212Substantially Equivalent

Ethicon Endo-Surgery Enseal G2 Cordless Tissue Sealers

Ethicon Endo-Surgery Inc, Cincinnati OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K123212 is the FDA 510(k) clearance record for ETHICON ENDO-SURGERY ENSEAL G2 CORDLESS TISSUE SEALERS, a class II device, cleared for Ethicon Endo-Surgery, LLC on under FDA product code PDG (Electrosurgical Vessel And/Or Tissue Sealer. With Built-In Generator.). FDA's definition for product code PDG reads: "Intended for any procedure where vessel ligation (cutting and sealing), soft tissue grasping and dissection are performed". FDA records list 185 510(k) clearances for Ethicon Endo-Surgery, LLC, from to . As of , FDA records show no recalls naming K123212.

Clearance record

Decision date
Received
(144 days to decision)
Product code
PDG Electrosurgical Vessel And/Or Tissue Sealer. With Built-In Generator.
Regulation
21 CFR 878.4400
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Ethicon Endo-Surgery, LLC 4545 Creek Rd., Cincinnati OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PDG

Trailing 12 months

FDA records hold no clearances under product code PDG in the trailing twelve months.

FDA records show no clearances under product code PDG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PDG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260