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

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

Pre-market Notification Details

• Device ID: K951625
• 510k Number: K951625
• Device Name: KARL STORZ KOH NEEDLE HOLDERS, FORCEPS FOR SUTURING, SUTURE SCISSORS, TISSUE PROBES, INJECTION NEEDLE, IRRIGATION INSTRT
• Classification: Laparoscope, General & Plastic Surgery
• 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: GCJ
• CFR Regulation Number: 876.1500 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-04-07
• Decision Date: 1995-05-16

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04048551001110	K951625	000
04048551098165	K951625	000
04048551098196	K951625	000
04048551098219	K951625	000
04048551098233	K951625	000
04048551098257	K951625	000
04048551098417	K951625	000
04048551098431	K951625	000
04048551098455	K951625	000
04048551098578	K951625	000
04048551098592	K951625	000
04048551098615	K951625	000
04048551098639	K951625	000
04048551098653	K951625	000
04048551098141	K951625	000
04048551098097	K951625	000
04048551008720	K951625	000
04048551008799	K951625	000
04048551008898	K951625	000
04048551008973	K951625	000
04048551009048	K951625	000
04048551009116	K951625	000
04048551095348	K951625	000
04048551095362	K951625	000
04048551095829	K951625	000
04048551097915	K951625	000
04048551097939	K951625	000
04048551097946	K951625	000
04048551097960	K951625	000
04048551098677	K951625	000
04048551098691	K951625	000
04048551258149	K951625	000
04048551265352	K951625	000
04048551265369	K951625	000
04048551265376	K951625	000
04048551292242	K951625	000
04048551346709	K951625	000
04048551348055	K951625	000
04048551359105	K951625	000
04048551364994	K951625	000
04048551365007	K951625	000
04048551365014	K951625	000
04048551365021	K951625	000
04048551365366	K951625	000
04048551121306	K951625	000
04048551121290	K951625	000
04048551098721	K951625	000
04048551098769	K951625	000
04048551098783	K951625	000
04048551098981	K951625	000
04048551101537	K951625	000
04048551101551	K951625	000
04048551101568	K951625	000
04048551101582	K951625	000
04048551101605	K951625	000
04048551101629	K951625	000
04048551101643	K951625	000
04048551101667	K951625	000
04048551101742	K951625	000
04048551365373	K951625	000