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FDA 510(k)

GIBBONS STERILE TROCAR KITS

K-Number: K012198 · 2001-08-09

ApplicantGibbons Surgical Corp.
Decision Date2001-08-09
Product CodeFBQ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GIBBONS STERILE TROCAR KITS is the device name listed in this FDA 510(k) record. The listed applicant is Gibbons Surgical Corp.. It received FDA 510(k) clearance on 2001-08-09 under 510(k) number K012198. 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 GIBBONS STERILE TROCAR KITS?

GIBBONS STERILE TROCAR KITS is a medical device that received FDA 510(k) clearance on 2001-08-09. The listed applicant is Gibbons Surgical Corp.. The 510(k) number is K012198.

When did GIBBONS STERILE TROCAR KITS receive FDA 510(k) clearance?

GIBBONS STERILE TROCAR KITS received FDA 510(k) clearance on 2001-08-09, under 510(k) number K012198.

Who is the listed applicant for GIBBONS STERILE TROCAR KITS?

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

What is the FDA product code for GIBBONS STERILE TROCAR KITS?

The FDA product code for GIBBONS STERILE TROCAR KITS 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 Gibbons 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.

K010779MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT

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.

K980804SABRE BT BLUNT0TIP SURGICAL TROCAREndoscopic Concepts, Inc.K944640LAPAROSCOPIC SURGICAL INSTRUMENT/ACCESSORY KITGabris Surgical Corp.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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