FDA 510(k)

Bi-Blade Vitrectomy Cutter

K-Number: K153168 · 2016-04-29

ApplicantMedical Instrument Development Laboratories

Decision Date2016-04-29

Product CodeHQE

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

Bi-Blade Vitrectomy Cutter is the device name listed in this FDA 510(k) record. The listed applicant is Medical Instrument Development Laboratories. It received FDA 510(k) clearance on 2016-04-29 under 510(k) number K153168. 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 Bi-Blade Vitrectomy Cutter?

Bi-Blade Vitrectomy Cutter is a medical device that received FDA 510(k) clearance on 2016-04-29. The listed applicant is Medical Instrument Development Laboratories. The 510(k) number is K153168.

When did Bi-Blade Vitrectomy Cutter receive FDA 510(k) clearance?

Bi-Blade Vitrectomy Cutter received FDA 510(k) clearance on 2016-04-29, under 510(k) number K153168.

Who is the listed applicant for Bi-Blade Vitrectomy Cutter?

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

What is the FDA product code for Bi-Blade Vitrectomy Cutter?

The FDA product code for Bi-Blade Vitrectomy Cutter is HQE.

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, LLC K170183Cetus system, Cetus probeA.R.C Laser GmbH

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.