Vac (Oscillating Vitrector)

FDA 510(k) K881520 · B&B Medical Assoc., Inc.

Substantially Equivalent

510(k) numberK881520

Submission

Device name
Vac (Oscillating Vitrector)
Applicant
B&B Medical Assoc., Inc.
Danvers, MA, US
Received
April 11, 1988
Decision date
September 7, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HQE – Instrument, Vitreous Aspiration And Cutting, Ac-Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 886.4150
Specialty
Ophthalmic

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More from Visioncare Devices, Inc.

510(k)DeviceDecision
K881707Introcular Fluid InjectorFIH · Traditional 10/21/1988SE
K881519Vac-G (Guillotine Vitrector)HQE · Traditional 09/08/1988SE
K881518Infusion HandleKYG · Traditional 08/22/1988SE
K881517B & B I/A HandpieceKYG · Traditional 08/22/1988SE

Questions and answers

When was Vac (Oscillating Vitrector) cleared by the FDA?

Vac (Oscillating Vitrector) (K881520) received a 510(k) decision of Substantially Equivalent on September 7, 1988, 149 days after the submission was received.

What is the product code of K881520?

The FDA product code is HQE – Instrument, Vitreous Aspiration And Cutting, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.4150.