OPHTHALMIC PAO VALVE— 510(k) K882536

Name: FDA 510(k) clearance K882536
Creator: U.S. Food and Drug Administration
Published: 1988-09-09

Substantially Equivalent

Look, Inc.

FDA 510(k) clearance K882536 for OPHTHALMIC PAO VALVE, Substantially Equivalent on 1988-09-09. Applicant: Look, Inc.. Device class: 2.

Clearance details

Applicant: Look, Inc.
Product code: Code FMF
Device class: Class 2
Regulation: 21 CFR 880.5860
Advisory panel: General Hospital
Date received: 1988-06-21
Decision date: 1988-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boston, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

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.