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FDA 510(k)

NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-GU USE

K-Number: K926016 · 1993-11-12

ApplicantZinnanti Surgical Instruments, Inc.
Decision Date1993-11-12
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-GU 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 1993-11-12 under 510(k) number K926016. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-GU USE?

NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-GU USE is a medical device that received FDA 510(k) clearance on 1993-11-12. The listed applicant is Zinnanti Surgical Instruments, Inc.. The 510(k) number is K926016.

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

NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-GU USE received FDA 510(k) clearance on 1993-11-12, under 510(k) number K926016.

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

The FDA product code for NEEDLE HOLDERS & ACCESS FOR LAPAR SURG-GU USE is GCJ.

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Other records listing Zinnanti Surgical Instruments, Inc. as applicant

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Related Devices (Code: GCJ)

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.

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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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