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FDA 510(k)

INNOVATIVE SURGICAL(R) MANGUM KNOT PUSHER

K-Number: K945394 · 1995-01-27

ApplicantInnovative Surgical, Inc.
Decision Date1995-01-27
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INNOVATIVE SURGICAL(R) MANGUM KNOT PUSHER is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Surgical, Inc.. It received FDA 510(k) clearance on 1995-01-27 under 510(k) number K945394. 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 INNOVATIVE SURGICAL(R) MANGUM KNOT PUSHER?

INNOVATIVE SURGICAL(R) MANGUM KNOT PUSHER is a medical device that received FDA 510(k) clearance on 1995-01-27. The listed applicant is Innovative Surgical, Inc.. The 510(k) number is K945394.

When did INNOVATIVE SURGICAL(R) MANGUM KNOT PUSHER receive FDA 510(k) clearance?

INNOVATIVE SURGICAL(R) MANGUM KNOT PUSHER received FDA 510(k) clearance on 1995-01-27, under 510(k) number K945394.

Who is the listed applicant for INNOVATIVE SURGICAL(R) MANGUM KNOT PUSHER?

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

What is the FDA product code for INNOVATIVE SURGICAL(R) MANGUM KNOT PUSHER?

The FDA product code for INNOVATIVE SURGICAL(R) MANGUM KNOT PUSHER is GCJ.

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Other records listing Innovative Surgical, 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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