VAC-G (GUILLOTINE VITRECTOR)— 510(k) K881519

Name: FDA 510(k) clearance K881519
Creator: U.S. Food and Drug Administration
Published: 1988-09-08

Substantially Equivalent

B&B Medical Assoc., Inc.

FDA 510(k) clearance K881519 for VAC-G (GUILLOTINE VITRECTOR), Substantially Equivalent on 1988-09-08. Applicant: B&B Medical Assoc., Inc.. Device class: 2.

Clearance details

Applicant: B&B Medical Assoc., Inc.
Product code: Code HQE
Device class: Class 2
Regulation: 21 CFR 886.4150
Advisory panel: Ophthalmic
Date received: 1988-04-11
Decision date: 1988-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danvers, MA, US

Download summary PDF View on FDA.gov ↗

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K881707 — INTROCULAR FLUID INJECTOR1988-10-21
K881520 — VAC (OSCILLATING VITRECTOR)1988-09-07
K881517 — B & B I/A HANDPIECE1988-08-22
K881518 — INFUSION HANDLE1988-08-22

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.