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FDA 510(k)

ENDO-ASSIST LAPAROSCOPIC INSTRUMENTS

K-Number: K941494 · 1994-04-22

ApplicantSharpe Endosurgical Corp.
Decision Date1994-04-22
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

ENDO-ASSIST LAPAROSCOPIC INSTRUMENTS 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 1994-04-22 under 510(k) number K941494. 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 ENDO-ASSIST LAPAROSCOPIC INSTRUMENTS?

ENDO-ASSIST LAPAROSCOPIC INSTRUMENTS is a medical device that received FDA 510(k) clearance on 1994-04-22. The listed applicant is Sharpe Endosurgical Corp.. The 510(k) number is K941494.

When did ENDO-ASSIST LAPAROSCOPIC INSTRUMENTS receive FDA 510(k) clearance?

ENDO-ASSIST LAPAROSCOPIC INSTRUMENTS received FDA 510(k) clearance on 1994-04-22, under 510(k) number K941494.

Who is the listed applicant for ENDO-ASSIST LAPAROSCOPIC INSTRUMENTS?

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 ENDO-ASSIST LAPAROSCOPIC INSTRUMENTS?

The FDA product code for ENDO-ASSIST LAPAROSCOPIC INSTRUMENTS is HET.

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.

K914967SHARP ENDOKNOT PUSHER

Related Devices (Code: HET)

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.

K250939SIRIUS Endoscope System (PR-SI-1230)Precision Robotics (Hong Kong) LimitedK243821i-CutA.M.I. Agency For Medical Innovations GmbHK221642SIRIUS Endoscope SystemPrecision Robotics (Hong Kong) LimitedK210116Video Endoscopy System, 3D Video Endoscopy SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.K201832Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5Olympus Medical Systems Corp.K210104SurroundScope System270surgical , Ltd.

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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