KARL STORZ HOPKINS I RIGID AUTOCLAVABLE TELESCOPE, KARL STORZ HOPKINS II RIGID AUTOCLAVABLE TELESCOPE

Laparoscope, General & Plastic Surgery

KARL STORZ ENDOSCOPY-AMERICA, INC.

The following data is part of a premarket notification filed by Karl Storz Endoscopy-america, Inc. with the FDA for Karl Storz Hopkins I Rigid Autoclavable Telescope, Karl Storz Hopkins Ii Rigid Autoclavable Telescope.

Pre-market Notification Details

• Device ID: K935279
• 510k Number: K935279
• Device Name: KARL STORZ HOPKINS I RIGID AUTOCLAVABLE TELESCOPE, KARL STORZ HOPKINS II RIGID AUTOCLAVABLE TELESCOPE
• Classification: Laparoscope, General & Plastic Surgery
• Applicant: KARL STORZ ENDOSCOPY-AMERICA, INC. 10111 W. JEFFERSON BLVD. Culver City, CA 90232 -3578
• Contact: Susie S Chen
• Correspondent: Susie S Chen; KARL STORZ ENDOSCOPY-AMERICA, INC. 10111 W. JEFFERSON BLVD. Culver City, CA 90232 -3578
• Product Code: GCJ
• CFR Regulation Number: 876.1500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-11-03
• Decision Date: 1994-09-12

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04048551090497	K935279	000
04048551090381	K935279	000
04048551384183	K935279	000
04048551095621	K935279	000
04048551314661	K935279	000