KARL STORZ FIXED MAGNIFICATION TELESCOPE/KS VARIABLE MAGNIFICATION TELESCOPE

Hysteroscope (and Accessories)

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 Fixed Magnification Telescope/ks Variable Magnification Telescope.

Pre-market Notification Details

• Device ID: K935716
• 510k Number: K935716
• Device Name: KARL STORZ FIXED MAGNIFICATION TELESCOPE/KS VARIABLE MAGNIFICATION TELESCOPE
• Classification: Hysteroscope (and Accessories)
• Applicant: KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600
• Contact: Betty M Johnson
• Correspondent: Betty M Johnson; KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600
• Product Code: HIH
• CFR Regulation Number: 884.1690 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-11-30
• Decision Date: 1995-11-16

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04048551257371	K935716	000
04048551257418	K935716	000
04048551094198	K935716	000