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FDA 510(k)

SHARP ENDOKNOT PUSHER

K-Number: K914967 · 1991-11-22

ApplicantSharpe Endosurgical Corp.
Decision Date1991-11-22
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SHARP ENDOKNOT PUSHER is the device name listed in this FDA 510(k) record. The listed applicant is Sharpe Endosurgical Corp.. It received FDA 510(k) clearance on 1991-11-22 under 510(k) number K914967. 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 SHARP ENDOKNOT PUSHER?

SHARP ENDOKNOT PUSHER is a medical device that received FDA 510(k) clearance on 1991-11-22. The listed applicant is Sharpe Endosurgical Corp.. The 510(k) number is K914967.

When did SHARP ENDOKNOT PUSHER receive FDA 510(k) clearance?

SHARP ENDOKNOT PUSHER received FDA 510(k) clearance on 1991-11-22, under 510(k) number K914967.

Who is the listed applicant for SHARP ENDOKNOT PUSHER?

The FDA 510(k) record lists Sharpe Endosurgical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SHARP ENDOKNOT PUSHER?

The FDA product code for SHARP ENDOKNOT PUSHER is GCJ.

Related Clinical Trials

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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Other records listing Sharpe Endosurgical Corp. 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.

K941494ENDO-ASSIST LAPAROSCOPIC INSTRUMENTS

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

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