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FDA 510(k)

ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100

K-Number: K062259 · 2006-08-15

ApplicantIscience Surgical
Decision Date2006-08-15
Product CodeMPA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100 is the device name listed in this FDA 510(k) record. The listed applicant is Iscience Surgical. It received FDA 510(k) clearance on 2006-08-15 under 510(k) number K062259. 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 ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100?

ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100 is a medical device that received FDA 510(k) clearance on 2006-08-15. The listed applicant is Iscience Surgical. The 510(k) number is K062259.

When did ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100 receive FDA 510(k) clearance?

ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100 received FDA 510(k) clearance on 2006-08-15, under 510(k) number K062259.

Who is the listed applicant for ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100?

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

What is the FDA product code for ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100?

The FDA product code for ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100 is MPA.

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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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