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Vacuum Handle Model I/A - 1

by Cutler Medical Instruments 510(k)

Active United States

510(k) K862343

Overview

This device is an instrument for vitreous aspiration and cutting, AC-powered, as defined in the device name and openFDA data. It is classified as a Class II medical device under regulation number 886.4150. The device is identified by the model number VACUUM HANDLE MODEL I/A - 1 and product code HQE.

It was granted FDA 510(k) clearance (K862343) on July 11, 1986, following a traditional review process. The device is manufactured by Cutler Medical Instruments in Santa Monica, California. It is intended for ophthalmic use, as indicated by the advisory committee designation OP and medical specialty description Ophthalmic.

AI-generated from registry data, 6 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK862343 Date11 Jul 1986ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
HQE
Device Class
Class II
Regulation
21 CFR Part 886.4150
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Other devices from Cutler Medical Instruments

  • Placido Disc

    Class I

Questions

  • What is the VACUUM HANDLE MODEL I/A - 1 used for?

    The VACUUM HANDLE MODEL I/A - 1 is an instrument designed for vitreous aspiration and cutting during ophthalmic procedures, as specified in its device name and FDA classification under regulation 886.4150 for vitreous aspiration and cutting, AC-powered devices.

  • How is the VACUUM HANDLE MODEL I/A - 1 powered and what is its regulatory pathway?

    The device is AC-powered and received FDA 510(k) clearance through a traditional review process under K862343 on July 11, 1986, confirming substantial equivalence to a legally marketed predicate device.

  • Who manufactures the VACUUM HANDLE MODEL I/A - 1 and where is it made?

    The VACUUM HANDLE MODEL I/A - 1 is manufactured by Cutler Medical Instruments, located at 4607 Kenneth Ave., Santa Monica, California, 93455, United States, as listed in the device’s registration and applicant details.