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FDA 510(k)

INFINITY(R) TRANSILLUMINATOR EXAMINATION LIGHT

K-Number: K912252 · 1991-06-27

ApplicantFiberoptic Medical Products, Inc.
Decision Date1991-06-27
Product CodeFST
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

INFINITY(R) TRANSILLUMINATOR EXAMINATION LIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Fiberoptic Medical Products, Inc.. It received FDA 510(k) clearance on 1991-06-27 under 510(k) number K912252. The device is classified under product code FST. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFINITY(R) TRANSILLUMINATOR EXAMINATION LIGHT?

INFINITY(R) TRANSILLUMINATOR EXAMINATION LIGHT is a medical device that received FDA 510(k) clearance on 1991-06-27. The listed applicant is Fiberoptic Medical Products, Inc.. The 510(k) number is K912252.

When did INFINITY(R) TRANSILLUMINATOR EXAMINATION LIGHT receive FDA 510(k) clearance?

INFINITY(R) TRANSILLUMINATOR EXAMINATION LIGHT received FDA 510(k) clearance on 1991-06-27, under 510(k) number K912252.

Who is the listed applicant for INFINITY(R) TRANSILLUMINATOR EXAMINATION LIGHT?

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

What is the FDA product code for INFINITY(R) TRANSILLUMINATOR EXAMINATION LIGHT?

The FDA product code for INFINITY(R) TRANSILLUMINATOR EXAMINATION LIGHT is FST.

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Other records listing Fiberoptic Medical Products, 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.

K944686FIBEROPTIC LARYNGOSCOPE HANDLEK933598ENDOSTAR(TM) STYLETK921393IMAGICA MICRO-ENDOSCOPEK883779WALLABY(TM) BLANKET

Related Devices (Code: FST)

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.

K200874TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal EndInnovasis, Inc.K122637LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999Stryker SpineK113697EIGR SURGICAL ILLUMINATION SYSTEMInvuity, Inc.K113330CABLECAPSensormedK102266ISOLED AC-POWERED LED HEADLIGHT SYSTEMIsolux, LLCK101496CABLECAP MODEL: WLF, STZ, ACMSensormed

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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