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FDA 510(k)

MBI FIBEROPTIC ENDO-ILLUMINATOR

K-Number: K961036 · 1996-07-15

ApplicantM.B. Industries, Inc.
Decision Date1996-07-15
Product CodeMPA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MBI FIBEROPTIC ENDO-ILLUMINATOR is the device name listed in this FDA 510(k) record. The listed applicant is M.B. Industries, Inc.. It received FDA 510(k) clearance on 1996-07-15 under 510(k) number K961036. The device is classified under product code MPA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MBI FIBEROPTIC ENDO-ILLUMINATOR?

MBI FIBEROPTIC ENDO-ILLUMINATOR is a medical device that received FDA 510(k) clearance on 1996-07-15. The listed applicant is M.B. Industries, Inc.. The 510(k) number is K961036.

When did MBI FIBEROPTIC ENDO-ILLUMINATOR receive FDA 510(k) clearance?

MBI FIBEROPTIC ENDO-ILLUMINATOR received FDA 510(k) clearance on 1996-07-15, under 510(k) number K961036.

Who is the listed applicant for MBI FIBEROPTIC ENDO-ILLUMINATOR?

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

What is the FDA product code for MBI FIBEROPTIC ENDO-ILLUMINATOR?

The FDA product code for MBI FIBEROPTIC ENDO-ILLUMINATOR is MPA.

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 M.B. Industries, 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.

K964553MBI CO-AXIAL ILLUMINATED RETINAL PICKK964405MBI ILLUMINATED RETINAL PICK

Related Devices (Code: MPA)

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.

K253468Nova Eye iTrack™ 250A Canaloplasty Microcatheter (iTrack™ 250A)Nova Eye, Inc.K242184Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);Alcon Laboratories, Inc.K233653Midfield Light Pipe, 23ga (3269.M06-00); Midfield Light Pipe, 25ga (3269.M05-00); Midfield Light Pipe, 27ga (3269.M04-00)Peregrine Surgical, LLCK221872ITrack Advance Canaloplasty Microcatheter with Advanced Delivery SystemNova Eye Inc. (Business Name Nova Eye Medical)K202670Nam illumination probe with chopperOculight , Ltd.K080067ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETERIscience Interventional

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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