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FDA 510(k)

NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-OB/GYN USE

K-Number: K926021 · 1994-04-07

ApplicantZinnanti Surgical Instruments, Inc.
Decision Date1994-04-07
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-OB/GYN USE 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 1994-04-07 under 510(k) number K926021. The device is classified under product code HET. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-OB/GYN USE?

NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-OB/GYN USE is a medical device that received FDA 510(k) clearance on 1994-04-07. The listed applicant is Zinnanti Surgical Instruments, Inc.. The 510(k) number is K926021.

When did NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-OB/GYN USE receive FDA 510(k) clearance?

NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-OB/GYN USE received FDA 510(k) clearance on 1994-04-07, under 510(k) number K926021.

Who is the listed applicant for NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-OB/GYN USE?

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 NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-OB/GYN USE?

The FDA product code for NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-OB/GYN USE is HET.

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Other records listing Zinnanti Surgical Instruments, Inc. as applicant

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Official Source

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

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