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FDA 510(k)

UTERINE INJECTOR WITH SPRING

K-Number: K941457 · 1995-01-24

ApplicantZinnanti Surgical Instruments, Inc.
Decision Date1995-01-24
Product CodeLKF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

UTERINE INJECTOR WITH SPRING is the device name listed in this FDA 510(k) record. The listed applicant is Zinnanti Surgical Instruments, Inc.. It received FDA 510(k) clearance on 1995-01-24 under 510(k) number K941457. The device is classified under product code LKF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UTERINE INJECTOR WITH SPRING?

UTERINE INJECTOR WITH SPRING is a medical device that received FDA 510(k) clearance on 1995-01-24. The listed applicant is Zinnanti Surgical Instruments, Inc.. The 510(k) number is K941457.

When did UTERINE INJECTOR WITH SPRING receive FDA 510(k) clearance?

UTERINE INJECTOR WITH SPRING received FDA 510(k) clearance on 1995-01-24, under 510(k) number K941457.

Who is the listed applicant for UTERINE INJECTOR WITH SPRING?

The FDA 510(k) record lists Zinnanti Surgical Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UTERINE INJECTOR WITH SPRING?

The FDA product code for UTERINE INJECTOR WITH SPRING is LKF.

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Other records listing Zinnanti Surgical Instruments, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K925501NYLON COATED SPECULAK941458UTERINE MANIPULATOR/INJECTOR WITH SPRINGK925560ZSI LOOP, ZSI BALL & ZSI NEEDLE ELECTRODESK925957SCISSORS FOR LAPAROSCOPIC SURGERY OB/GYN USEK925960FORCEPS FOR LAPAROSCOPIC SURGERY OB/GYN USEK926021NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-OB/GYN USE

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Related Devices (Code: LKF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253403FemVue® Controlled Saline-Air Device (FSA-300)Femasys, Inc.K252260RELIEEV HSG Catheter (HSG7FA1)Li Medical Corporation , Ltd.K242002FemVue MINI Saline-Air DeviceFemasys, Inc.K240364RELIEEV Uterine Manipulator Injector (CUMI 5.0)Li Medical Corporation , Ltd.K241693FemChec Controlled Saline-Air Device (FCD-250)Femasys, Inc.K222798Rejoni Intrauterine CatheterRejoni, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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