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FDA 510(k)

GM OPTI*CAM CAMERA WITH FIBER OPTIC LIGHT

K-Number: K941660 · 1994-05-24

ApplicantGm Engineering, Inc.
Decision Date1994-05-24
Product CodeKYH
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GM OPTI*CAM CAMERA WITH FIBER OPTIC LIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Gm Engineering, Inc.. It received FDA 510(k) clearance on 1994-05-24 under 510(k) number K941660. The device is classified under product code KYH. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GM OPTI*CAM CAMERA WITH FIBER OPTIC LIGHT?

GM OPTI*CAM CAMERA WITH FIBER OPTIC LIGHT is a medical device that received FDA 510(k) clearance on 1994-05-24. The listed applicant is Gm Engineering, Inc.. The 510(k) number is K941660.

When did GM OPTI*CAM CAMERA WITH FIBER OPTIC LIGHT receive FDA 510(k) clearance?

GM OPTI*CAM CAMERA WITH FIBER OPTIC LIGHT received FDA 510(k) clearance on 1994-05-24, under 510(k) number K941660.

Who is the listed applicant for GM OPTI*CAM CAMERA WITH FIBER OPTIC LIGHT?

The FDA 510(k) record lists Gm Engineering, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GM OPTI*CAM CAMERA WITH FIBER OPTIC LIGHT?

The FDA product code for GM OPTI*CAM CAMERA WITH FIBER OPTIC LIGHT is KYH.

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 Gm Engineering, Inc. 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.

K953348ARTICULATING RETRACTOR TISSUE RETRACTORSK942626CONTINUOUS FLOW BIOPSY PROBEK932394BERNSTEIN(TM) UTERINE MANIPULATORK941661GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHTK942703GM REUSABLE AND DISPOSABLE TROCAR AND GM REUSABLE AND DISPOSABLE ULTRA-LIGHT CANNULAK941662GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHT

View all 11 devices →

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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