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FDA 510(k)

BARE-FIBER ENDOILLUMINATOR

K-Number: K933208 · 1993-12-14

ApplicantSurgical Technologies, Inc.
Decision Date1993-12-14
Product CodeHQE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

BARE-FIBER ENDOILLUMINATOR is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Technologies, Inc.. It received FDA 510(k) clearance on 1993-12-14 under 510(k) number K933208. The device is classified under product code HQE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BARE-FIBER ENDOILLUMINATOR?

BARE-FIBER ENDOILLUMINATOR is a medical device that received FDA 510(k) clearance on 1993-12-14. The listed applicant is Surgical Technologies, Inc.. The 510(k) number is K933208.

When did BARE-FIBER ENDOILLUMINATOR receive FDA 510(k) clearance?

BARE-FIBER ENDOILLUMINATOR received FDA 510(k) clearance on 1993-12-14, under 510(k) number K933208.

Who is the listed applicant for BARE-FIBER ENDOILLUMINATOR?

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

What is the FDA product code for BARE-FIBER ENDOILLUMINATOR?

The FDA product code for BARE-FIBER ENDOILLUMINATOR is HQE.

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Other records listing Surgical Technologies, 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.

K941992CYSTOSCOPEK942029ARTHROSCOPEK946136INFINITECH LIGHTED INFUSION CANNULAK952566OSCILFLATORK951918SURGICAL TECHNOLOGIES, INC. SYRINGEK950683ARTHROGRAM TRAY

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Related Devices (Code: HQE)

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.

K212763UniVit HE, UniVit UHSVisioncare Devices, LLCK170183Cetus system, Cetus probeA.R.C Laser GmbHK153168Bi-Blade Vitrectomy CutterMedical Instrument Development LaboratoriesK121675VERSAVITSynergetics, Inc.K120170PROCARE PLUS VITRECTOMY SYSTEMVisioncare Devices, Inc.K102222ULTIMATE VIT ENHAMCER (UVE)Medical Instrument Development Laboratories, Inc.

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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