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FDA 510(k)

EXTENSION HANDLE FOR ACUTOME PROBE

K-Number: K830037 · 1983-04-06

ApplicantPrecision Medical Instruments, Inc.
Decision Date1983-04-06
Product CodeHQE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

EXTENSION HANDLE FOR ACUTOME PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Precision Medical Instruments, Inc.. It received FDA 510(k) clearance on 1983-04-06 under 510(k) number K830037. 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 EXTENSION HANDLE FOR ACUTOME PROBE?

EXTENSION HANDLE FOR ACUTOME PROBE is a medical device that received FDA 510(k) clearance on 1983-04-06. The listed applicant is Precision Medical Instruments, Inc.. The 510(k) number is K830037.

When did EXTENSION HANDLE FOR ACUTOME PROBE receive FDA 510(k) clearance?

EXTENSION HANDLE FOR ACUTOME PROBE received FDA 510(k) clearance on 1983-04-06, under 510(k) number K830037.

Who is the listed applicant for EXTENSION HANDLE FOR ACUTOME PROBE?

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

What is the FDA product code for EXTENSION HANDLE FOR ACUTOME PROBE?

The FDA product code for EXTENSION HANDLE FOR ACUTOME PROBE is HQE.

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Other records listing Precision Medical Instruments, 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.

K852758INFUSION CANNULAMK832560ASPIRATING HANDLE W/BACKFLUSHING CAPABK791212VITRECTOMY INTEGRATING TRAY OCUTOME/FRAG

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

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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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