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FDA 510(k)

END-IRRIGATING ENDOILLUMINATOR

K-Number: K931546 · 1994-02-09

ApplicantInfinitech, Inc.
Decision Date1994-02-09
Product CodeFST
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

END-IRRIGATING ENDOILLUMINATOR is the device name listed in this FDA 510(k) record. The listed applicant is Infinitech, Inc.. It received FDA 510(k) clearance on 1994-02-09 under 510(k) number K931546. 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 END-IRRIGATING ENDOILLUMINATOR?

END-IRRIGATING ENDOILLUMINATOR is a medical device that received FDA 510(k) clearance on 1994-02-09. The listed applicant is Infinitech, Inc.. The 510(k) number is K931546.

When did END-IRRIGATING ENDOILLUMINATOR receive FDA 510(k) clearance?

END-IRRIGATING ENDOILLUMINATOR received FDA 510(k) clearance on 1994-02-09, under 510(k) number K931546.

Who is the listed applicant for END-IRRIGATING ENDOILLUMINATOR?

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

What is the FDA product code for END-IRRIGATING ENDOILLUMINATOR?

The FDA product code for END-IRRIGATING ENDOILLUMINATOR is FST.

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Other records listing Infinitech, 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.

K972506INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATORK971950INFINITECH MULTI-SPOT SLIT LAMP LASER ADAPTERK951627INFINITECH HIGH INTENSITY XENON LIGHT SOURCE SYSTEMK931264INFINITECH OTOPROBEK935441INFINITECH BREATH EZ

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

View on FDA Database →

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

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