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510(k) K942450

ENDOPATH by Ethicon Endo-Surgery, Inc. — Product Code GBZ

K942450 is an FDA 510(k) premarket notification submitted by Ethicon Endo-Surgery, Inc. for the device "ENDOPATH". The FDA issued a decision of Substantially Equivalent on August 5, 1994. The device falls under product code GBZ (Catheter, Cholangiography), a Class I device regulated under 21 CFR 878.4200. Ethicon Endo-Surgery, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 1994
Date Received
May 23, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Cholangiography
Device Class
Class I
Regulation Number
878.4200
Review Panel
SU
Submission Type

Other clearances by Ethicon Endo-Surgery, Inc.

  • 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)

Other clearances for product code GBZ

  • K973621 — PRE-VIEW CHOLANGIOGRAPHY CLAMP (December 17, 1997)
  • K944790 — FLEXIBLE LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER (November 29, 1994)
  • K932228 — MICROVASIVE INSURG CHLOANGIOGRAPHIC CATHETER (August 10, 1993)
  • K926217 — TERUMO ANGIOGRAPHIC CATHETER FOR LAPOROSCOPIC USE (July 13, 1993)
  • K924212 — STRYKER ENDOSCOPY CHOLANGIOGRAM KIT (July 7, 1993)
  • K926143 — ANGIOLAPCATH CHOLANGIOGRAPHY KIT (July 7, 1993)
  • K925742 — CLARUS CHOLANGIOGRAM CATHETER KIT (June 1, 1993)
  • K924981 — OPERATIVE CHOLANGIOGRAM CATHETER (April 6, 1993)
  • K924480 — CHOLANGIOGRAPHY CLAMP (March 3, 1993)
  • K924128 — CHOLANGIOGRAPHY CATHETER (February 10, 1993)

FDA data resources