UTERINE MANIPULATOR/INJECTOR WITH SPRING

Cannula, Manipulator/injector, Uterine

ZINNANTI SURGICAL INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Zinnanti Surgical Instruments, Inc. with the FDA for Uterine Manipulator/injector With Spring.

Pre-market Notification Details

• Device ID: K941458
• 510k Number: K941458
• Device Name: UTERINE MANIPULATOR/INJECTOR WITH SPRING
• Classification: Cannula, Manipulator/injector, Uterine
• Applicant: ZINNANTI SURGICAL INSTRUMENTS, INC. 21540-B PRAIRIE ST. Chatsworth, CA 91311
• Contact: Trish Willging
• Correspondent: Trish Willging; ZINNANTI SURGICAL INSTRUMENTS, INC. 21540-B PRAIRIE ST. Chatsworth, CA 91311
• Product Code: LKF
• CFR Regulation Number: 884.4530 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-03-25
• Decision Date: 1995-01-25

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
20888937013638	K941458	000
20888937013225	K941458	000