Bi-Blade Vitrectomy Cutter— 510(k) K153168

Name: FDA 510(k) clearance K153168
Creator: U.S. Food and Drug Administration
Published: 2016-04-29

Substantially Equivalent

Medical Instrument Development Laboratories

FDA 510(k) clearance K153168 for Bi-Blade Vitrectomy Cutter, Substantially Equivalent on 2016-04-29. Applicant: Medical Instrument Development Laboratories. Device class: 2.

Clearance details

Applicant: Medical Instrument Development Laboratories
Product code: Code HQE
Device class: Class 2
Regulation: 21 CFR 886.4150
Advisory panel: Ophthalmic
Date received: 2015-11-02
Decision date: 2016-04-29
Decision: Substantially Equivalent
Clearance type: Special
Location: San Leandro, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HQE

view all

K212763 — UniVit HE, UniVit UHS2022-08-10
K170183 — Cetus system, Cetus probe2017-09-27
K141065 — CONSTELLATION VISION SYSTEM2014-08-22
K121675 — VERSAVIT2012-06-21
K120170 — PROCARE PLUS VITRECTOMY SYSTEM2012-05-30

Adverse events under product code HQE

product code HQE

Injury: 156
Malfunction: 565
Total: 721

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.