KARL STORZ DILATION SET, REDUCERS, THREAD SLEEVES, DISTANCE HOLDERS

Laparoscope, Gynecologic (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 Dilation Set, Reducers, Thread Sleeves, Distance Holders.

Pre-market Notification Details

• Device ID: K946359
• 510k Number: K946359
• Device Name: KARL STORZ DILATION SET, REDUCERS, THREAD SLEEVES, DISTANCE HOLDERS
• Classification: Laparoscope, Gynecologic (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: HET
• CFR Regulation Number: 884.1720 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-12-30
• Decision Date: 1995-05-11

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04048551257531	K946359	000
04048551257524	K946359	000