Skip to content

VAC (Oscillating Vitrector)

by B&B Medical Assoc., Inc.

510(k) K881520

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK881520 Date7 Sep 1988ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

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

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The VAC (Oscillating Vitrector) is an ophthalmic instrument designed for vitreous aspiration and cutting. It is an AC-powered device used in ophthalmic surgical procedures.

This device is supplied as a reusable instrument and requires appropriate cleaning and sterilization between uses. It is regulated under FDA 510(k) clearance K881520 with product code HQE and is classified as a Class II medical device.

Other devices from B&B Medical Assoc., Inc.

Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the VAC Oscillating Vitrector used for?

    The VAC Oscillating Vitrector is designed for vitreous aspiration and cutting in ophthalmic surgical procedures, enabling surgeons to remove and cut vitreous gel during eye surgery.

  • Is the VAC Oscillating Vitrector reusable or single-use?

    The VAC Oscillating Vitrector is supplied as a reusable instrument and must be cleaned and sterilized between each use to ensure safe and effective operation in surgical settings.

  • What powers the VAC Oscillating Vitrector and how is it operated?

    The VAC Oscillating Vitrector is an AC-powered device, meaning it operates using alternating current from a standard electrical source, and is used directly in ophthalmic surgical procedures.