ROOTMAN ORBITAL SURGERY INSTRUMENT SET— 510(k) K842697

Name: FDA 510(k) clearance K842697
Creator: U.S. Food and Drug Administration
Published: 1984-08-07

Substantially Equivalent

Downs Surgical , Ltd.

FDA 510(k) clearance K842697 for ROOTMAN ORBITAL SURGERY INSTRUMENT SET, Substantially Equivalent on 1984-08-07. Applicant: Downs Surgical , Ltd.. Device class: 1.

Clearance details

Applicant: Downs Surgical , Ltd.
Product code: Code HNR
Device class: Class 1
Regulation: 21 CFR 886.4350
Advisory panel: Ophthalmic
Date received: 1984-07-11
Decision date: 1984-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HNR

product code HNR

Malfunction: 497
Other: 1
Total: 498

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.