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FDA 510(k)

INFINITECH ASPIRATING LASER PROBE

K-Number: K946135 · 1995-04-18

ApplicantSurgical Technologies, Inc.
Decision Date1995-04-18
Product CodeHQE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

INFINITECH ASPIRATING LASER PROBE 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 1995-04-18 under 510(k) number K946135. 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 INFINITECH ASPIRATING LASER PROBE?

INFINITECH ASPIRATING LASER PROBE is a medical device that received FDA 510(k) clearance on 1995-04-18. The listed applicant is Surgical Technologies, Inc.. The 510(k) number is K946135.

When did INFINITECH ASPIRATING LASER PROBE receive FDA 510(k) clearance?

INFINITECH ASPIRATING LASER PROBE received FDA 510(k) clearance on 1995-04-18, under 510(k) number K946135.

Who is the listed applicant for INFINITECH ASPIRATING LASER PROBE?

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 INFINITECH ASPIRATING LASER PROBE?

The FDA product code for INFINITECH ASPIRATING LASER PROBE 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)

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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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