KARL STORZ HOK NEEDLE HOLDERS, FORCEPS FOR SUTURING, SUTURE SCISSORS, TISSUE PROBES, INJECTION NEEDLE, IRRIGATION INSTRT

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 Hok Needle Holders, Forceps For Suturing, Suture Scissors, Tissue Probes, Injection Needle, Irrigation Instrt.

Pre-market Notification Details

• Device ID: K950962
• 510k Number: K950962
• Device Name: KARL STORZ HOK NEEDLE HOLDERS, FORCEPS FOR SUTURING, SUTURE SCISSORS, TISSUE PROBES, INJECTION NEEDLE, IRRIGATION INSTRT
• Classification: Laparoscope, Gynecologic (and Accessories)
• Applicant: KARL STORZ ENDOSCOPY-AMERICA, INC. 600 CORPORATE POINTE Culver City, CA 90230 -7600
• Contact: Renate A Maclaren
• Correspondent: Renate A Maclaren; 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: 1995-03-02
• Decision Date: 1995-07-12

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04048551256107	K950962	000
04048551256091	K950962	000