KARL STORZ MONOPOLAR COAGULATION, NEEDLE, LOOP ELECTRODES

Coagulator-cutter, Endoscopic, Unipolar (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 Monopolar Coagulation, Needle, Loop Electrodes.

Pre-market Notification Details

• Device ID: K944793
• 510k Number: K944793
• Device Name: KARL STORZ MONOPOLAR COAGULATION, NEEDLE, LOOP ELECTRODES
• Classification: Coagulator-cutter, Endoscopic, Unipolar (and Accessories)
• Applicant: KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600
• Contact: Judith K Murphy
• Correspondent: Judith K Murphy; KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600
• Product Code: KNF
• CFR Regulation Number: 884.4160 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-09-28
• Decision Date: 1995-01-24

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04048551072110	K944793	000
04048551072097	K944793	000
04048551094440	K944793	000
04048551347645	K944793	000
04048551266687	K944793	000