Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

OMNIVIEW(TM) OPHTHALMIC FIBERENDO W/NEEDLEHOLDER

K-Number: K912522 · 1991-07-25

ApplicantSummit Technology, Inc.
Decision Date1991-07-25
Product CodeEQH
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

OMNIVIEW(TM) OPHTHALMIC FIBERENDO W/NEEDLEHOLDER is the device name listed in this FDA 510(k) record. The listed applicant is Summit Technology, Inc.. It received FDA 510(k) clearance on 1991-07-25 under 510(k) number K912522. The device is classified under product code EQH. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNIVIEW(TM) OPHTHALMIC FIBERENDO W/NEEDLEHOLDER?

OMNIVIEW(TM) OPHTHALMIC FIBERENDO W/NEEDLEHOLDER is a medical device that received FDA 510(k) clearance on 1991-07-25. The listed applicant is Summit Technology, Inc.. The 510(k) number is K912522.

When did OMNIVIEW(TM) OPHTHALMIC FIBERENDO W/NEEDLEHOLDER receive FDA 510(k) clearance?

OMNIVIEW(TM) OPHTHALMIC FIBERENDO W/NEEDLEHOLDER received FDA 510(k) clearance on 1991-07-25, under 510(k) number K912522.

Who is the listed applicant for OMNIVIEW(TM) OPHTHALMIC FIBERENDO W/NEEDLEHOLDER?

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

What is the FDA product code for OMNIVIEW(TM) OPHTHALMIC FIBERENDO W/NEEDLEHOLDER?

The FDA product code for OMNIVIEW(TM) OPHTHALMIC FIBERENDO W/NEEDLEHOLDER is EQH.

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 Summit Technology, 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.

K980675SUMMIT KRUMEICH-BARRAQUER MICROKERATOMEK926470LASER AND EMPHASIS SCLEROSTOMY TIPK915651OMNIMED HOLMIUM LASER AND DELIVERY SYSTEMK904470SUMMIT TECH 19/20 GAUGE OPHTHALMIC FIBERENDOSCOPE

Related Devices (Code: EQH)

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.

K945876WECO ENDOSCOPIC SYSTEM WITH FIBER OPTIC LIGHTWells Johnson Co.K954184JED-LIGHT FIBEROPTIC LIGHT SOURCEJedmed Instrument Co.K951829COLD LIGHT SOURCE LOS 150Laser-Optik-Systeme GmbH & Co. KGK932771BATTERY POWERED, DISPOSABLE ENDOSCOPE LIGHT SOURCEXomed-Treace, Inc.K941661GM OPTI*CAM CAMER WITH DENTAL FIBER OPTIC LIGHTGm Engineering, Inc.K941662GM OPTI*CAM CAMERA WITH ENT FIBER OPTIC LIGHTGm Engineering, 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.

↑