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510(k) K123212

ETHICON ENDO-SURGERY ENSEAL G2 CORDLESS TISSUE SEALERS by Ethicon Endo-Surgery, LLC — Product Code PDG

K123212 is an FDA 510(k) premarket notification submitted by Ethicon Endo-Surgery, LLC for the device "ETHICON ENDO-SURGERY ENSEAL G2 CORDLESS TISSUE SEALERS". The FDA issued a decision of Substantially Equivalent on March 8, 2013. The device falls under product code PDG (Electrosurgical Vessel And/Or Tissue Sealer. With Built-In Generator.), a Class II device regulated under 21 CFR 878.4400. Ethicon Endo-Surgery, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 2013
Date Received
October 15, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrosurgical Vessel And/Or Tissue Sealer. With Built-In Generator.
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type

Intended for any procedure where vessel ligation (cutting and sealing), soft tissue grasping and dissection are performed.

Other clearances by Ethicon Endo-Surgery, LLC

  • K260196 — ETHICON™ Circular Stapler (CDH21mm); ETHICON™ Circular Stapler (CDH25mm); ETHICO (May 11, 2026)
  • K252906 — ECHELON ENDOPATH Staple Line Reinforcement (ECH60R) (January 9, 2026)
  • K252739 — ETHICON™ 4000 45mm Compact Stapler (EC3DT45C); ETHICON™ 4000 45mm Standard Stapl (December 17, 2025)
  • K250835 — ETHICON 4000 60mm Compact Stapler (EC3D60C); ETHICON 4000 60mm Standard Stapler (May 14, 2025)
  • K243276 — ECHELON LINEAR™ Stapler 30mm Stapler (GTX30); ECHELON LINEAR™ Stapler 60mm Stapl (February 25, 2025)
  • K241630 — ECHELON 4000 60mm Compact Stapler (EC3D60C); ECHELON 4000 60mm Standard Stapler (October 28, 2024)
  • K241629 — ECHELON 3000 45mm Compact Stapler (ECH45C); Echelon 3000 45mm Standard Stapler (July 3, 2024)
  • K230387 — ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C); ENSEAL X1 Curved (April 13, 2023)
  • K223760 — ECHELON LINEAR™ 60 mm Cutter (GLC60);ECHELON LINEAR™ 80mm Cutter (GLC80);ECHELO (March 15, 2023)
  • K221790 — HARMONIC 700 Shears (February 28, 2023)

FDA data resources