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FDA 510(k)

LAPAROSCOPIC SURGICAL INSTRUMENT/ACCESSORY KIT

K-Number: K944640 · 1994-10-11

ApplicantGabris Surgical Corp.
Decision Date1994-10-11
Product CodeFBQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LAPAROSCOPIC SURGICAL INSTRUMENT/ACCESSORY KIT 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 1994-10-11 under 510(k) number K944640. The device is classified under product code FBQ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LAPAROSCOPIC SURGICAL INSTRUMENT/ACCESSORY KIT?

LAPAROSCOPIC SURGICAL INSTRUMENT/ACCESSORY KIT is a medical device that received FDA 510(k) clearance on 1994-10-11. The listed applicant is Gabris Surgical Corp.. The 510(k) number is K944640.

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

LAPAROSCOPIC SURGICAL INSTRUMENT/ACCESSORY KIT received FDA 510(k) clearance on 1994-10-11, under 510(k) number K944640.

Who is the listed applicant for LAPAROSCOPIC SURGICAL INSTRUMENT/ACCESSORY KIT?

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/ACCESSORY KIT?

The FDA product code for LAPAROSCOPIC SURGICAL INSTRUMENT/ACCESSORY KIT is FBQ.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 INSTRUMENTK944104GABRIS LAPAROSCOPIC SURGICAL KITSK943989LAPAROSCOPIC/ENDOSCOPIC INSTRUEMENTK944103LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTK930716LAPAROSCOPIC CHOLECYSTECTOMY INSTRUMENTATION

View all 7 devices →

Related Devices (Code: FBQ)

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.

K012198GIBBONS STERILE TROCAR KITSGibbons Surgical Corp.K980804SABRE BT BLUNT0TIP SURGICAL TROCAREndoscopic Concepts, Inc.K944104GABRIS LAPAROSCOPIC SURGICAL KITSGabris Surgical Corp.K942885AUTO SUTURE MODIFIED GRIPUnited States Surgical, A Division of Tyco HealthcK934724AESCULAP TROCAR INSTRUMENT SETAesculap, Inc.K904638TROCAR DISPOSABLEL.A.S.E.R., 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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