Nidek Model VST-4000

Q: What is the product code of K924353?

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.

FDA 510(k) K924353 · Nidek, Inc.

Substantially Equivalent

510(k) numberK924353

Submission

Device name: Nidek Model VST-4000
Applicant: Nidek, Inc.
Fremont, CA, US
Received: August 28, 1992
Decision date: March 29, 1993
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

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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Questions and answers

When was Nidek Model VST-4000 cleared by the FDA?

Nidek Model VST-4000 (K924353) received a 510(k) decision of Substantially Equivalent on March 29, 1993, 213 days after the submission was received.

What is the product code of K924353?

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.