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FDA 510(k)

LAPAROSCOPIC CHOLECYSTECTOMY INSTRUMENTATION

K-Number: K930716 · 1993-07-23

ApplicantGabris Surgical Corp.
Decision Date1993-07-23
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LAPAROSCOPIC CHOLECYSTECTOMY INSTRUMENTATION 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 1993-07-23 under 510(k) number K930716. 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 CHOLECYSTECTOMY INSTRUMENTATION?

LAPAROSCOPIC CHOLECYSTECTOMY INSTRUMENTATION is a medical device that received FDA 510(k) clearance on 1993-07-23. The listed applicant is Gabris Surgical Corp.. The 510(k) number is K930716.

When did LAPAROSCOPIC CHOLECYSTECTOMY INSTRUMENTATION receive FDA 510(k) clearance?

LAPAROSCOPIC CHOLECYSTECTOMY INSTRUMENTATION received FDA 510(k) clearance on 1993-07-23, under 510(k) number K930716.

Who is the listed applicant for LAPAROSCOPIC CHOLECYSTECTOMY INSTRUMENTATION?

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 CHOLECYSTECTOMY INSTRUMENTATION?

The FDA product code for LAPAROSCOPIC CHOLECYSTECTOMY INSTRUMENTATION 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 INSTRUEMENTK944103LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT

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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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