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FDA 510(k)

VACUUM HANDLE MODEL I/A - 1

K-Number: K862343 · 1986-07-11

ApplicantCutler Medical Instruments
Decision Date1986-07-11
Product CodeHQE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

VACUUM HANDLE MODEL I/A - 1 is the device name listed in this FDA 510(k) record. The listed applicant is Cutler Medical Instruments. It received FDA 510(k) clearance on 1986-07-11 under 510(k) number K862343. 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 VACUUM HANDLE MODEL I/A - 1?

VACUUM HANDLE MODEL I/A - 1 is a medical device that received FDA 510(k) clearance on 1986-07-11. The listed applicant is Cutler Medical Instruments. The 510(k) number is K862343.

When did VACUUM HANDLE MODEL I/A - 1 receive FDA 510(k) clearance?

VACUUM HANDLE MODEL I/A - 1 received FDA 510(k) clearance on 1986-07-11, under 510(k) number K862343.

Who is the listed applicant for VACUUM HANDLE MODEL I/A - 1?

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

What is the FDA product code for VACUUM HANDLE MODEL I/A - 1?

The FDA product code for VACUUM HANDLE MODEL I/A - 1 is HQE.

Related Clinical Trials

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.

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Other records listing Cutler Medical Instruments 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.

K854054PLACIDO DISC

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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