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FDA 510(k)

SYNTEC, INC. DISPOSABLE BARE END FIBER

K-Number: K971338 · 1997-05-06

ApplicantSyntec, Inc.
Decision Date1997-05-06
Product CodeMPA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SYNTEC, INC. DISPOSABLE BARE END FIBER is the device name listed in this FDA 510(k) record. The listed applicant is Syntec, Inc.. It received FDA 510(k) clearance on 1997-05-06 under 510(k) number K971338. 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 SYNTEC, INC. DISPOSABLE BARE END FIBER?

SYNTEC, INC. DISPOSABLE BARE END FIBER is a medical device that received FDA 510(k) clearance on 1997-05-06. The listed applicant is Syntec, Inc.. The 510(k) number is K971338.

When did SYNTEC, INC. DISPOSABLE BARE END FIBER receive FDA 510(k) clearance?

SYNTEC, INC. DISPOSABLE BARE END FIBER received FDA 510(k) clearance on 1997-05-06, under 510(k) number K971338.

Who is the listed applicant for SYNTEC, INC. DISPOSABLE BARE END FIBER?

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

What is the FDA product code for SYNTEC, INC. DISPOSABLE BARE END FIBER?

The FDA product code for SYNTEC, INC. DISPOSABLE BARE END FIBER 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.

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Other records listing Syntec, 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.

K002932PHACOGARDK980480SYNTEC VITMAN

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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