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FDA 510(k)

MBI ILLUMINATED RETINAL PICK

K-Number: K964405 · 1997-05-13

ApplicantM.B. Industries, Inc.
Decision Date1997-05-13
Product CodeMPA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MBI ILLUMINATED RETINAL PICK 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 1997-05-13 under 510(k) number K964405. 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 ILLUMINATED RETINAL PICK?

MBI ILLUMINATED RETINAL PICK is a medical device that received FDA 510(k) clearance on 1997-05-13. The listed applicant is M.B. Industries, Inc.. The 510(k) number is K964405.

When did MBI ILLUMINATED RETINAL PICK receive FDA 510(k) clearance?

MBI ILLUMINATED RETINAL PICK received FDA 510(k) clearance on 1997-05-13, under 510(k) number K964405.

Who is the listed applicant for MBI ILLUMINATED RETINAL PICK?

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 ILLUMINATED RETINAL PICK?

The FDA product code for MBI ILLUMINATED RETINAL PICK 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 PICKK961036MBI FIBEROPTIC ENDO-ILLUMINATOR

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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