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FDA 510(k)

LAPAROSCOPIC SURGICAL INSTRUMENT

K-Number: K953548 · 1995-09-19

ApplicantGabris Surgical Corp.
Decision Date1995-09-19
Product CodeHET
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LAPAROSCOPIC SURGICAL INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Gabris Surgical Corp.. It received FDA 510(k) clearance on 1995-09-19 under 510(k) number K953548. 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 LAPAROSCOPIC SURGICAL INSTRUMENT?

LAPAROSCOPIC SURGICAL INSTRUMENT is a medical device that received FDA 510(k) clearance on 1995-09-19. The listed applicant is Gabris Surgical Corp.. The 510(k) number is K953548.

When did LAPAROSCOPIC SURGICAL INSTRUMENT receive FDA 510(k) clearance?

LAPAROSCOPIC SURGICAL INSTRUMENT received FDA 510(k) clearance on 1995-09-19, under 510(k) number K953548.

Who is the listed applicant for LAPAROSCOPIC SURGICAL INSTRUMENT?

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

What is the FDA product code for LAPAROSCOPIC SURGICAL INSTRUMENT?

The FDA product code for LAPAROSCOPIC SURGICAL INSTRUMENT is HET.

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Other records listing Gabris Surgical 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.

K954774SHIELDED TROCAR (OBTURATOR)K944640LAPAROSCOPIC SURGICAL INSTRUMENT/ACCESSORY KITK944104GABRIS LAPAROSCOPIC SURGICAL KITSK943989LAPAROSCOPIC/ENDOSCOPIC INSTRUEMENTK944103LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTK930716LAPAROSCOPIC CHOLECYSTECTOMY INSTRUMENTATION

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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

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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