ENDOPATH

Catheter, Cholangiography

ETHICON ENDO-SURGERY, INC.

The following data is part of a premarket notification filed by Ethicon Endo-surgery, Inc. with the FDA for Endopath.

Pre-market Notification Details

• Device ID: K942450
• 510k Number: K942450
• Device Name: ENDOPATH
• Classification: Catheter, Cholangiography
• Applicant: ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242
• Contact: Claudia L Berner
• Correspondent: Claudia L Berner; ETHICON ENDO-SURGERY, INC. 4545 CREEK RD. Cincinnati, OH 45242
• Product Code: GBZ
• CFR Regulation Number: 878.4200 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-05-23
• Decision Date: 1994-08-05