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FDA 510(k)

LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT

K-Number: K944103 · 1994-09-12

ApplicantGabris Surgical Corp.
Decision Date1994-09-12
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LAPAROSCOPIC/ENDOSCOPIC 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 1994-09-12 under 510(k) number K944103. 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 LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT?

LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT is a medical device that received FDA 510(k) clearance on 1994-09-12. The listed applicant is Gabris Surgical Corp.. The 510(k) number is K944103.

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

LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT received FDA 510(k) clearance on 1994-09-12, under 510(k) number K944103.

Who is the listed applicant for LAPAROSCOPIC/ENDOSCOPIC 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/ENDOSCOPIC INSTRUMENT?

The FDA product code for LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT is GCJ.

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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)K953548LAPAROSCOPIC SURGICAL INSTRUMENTK944640LAPAROSCOPIC SURGICAL INSTRUMENT/ACCESSORY KITK944104GABRIS LAPAROSCOPIC SURGICAL KITSK943989LAPAROSCOPIC/ENDOSCOPIC INSTRUEMENTK930716LAPAROSCOPIC CHOLECYSTECTOMY INSTRUMENTATION

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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.

K262397CuratOR EX2742Eizo CorporationK260884UNIDRIVE Select SystemKarl Storz SE & CO. KGK260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony CorporationK261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.Inc

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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