MANUAL OPHTHALMIC SURGICAL INSTRUMENTS— 510(k) K861141

Substantially Equivalent

CooperVision, Inc.

FDA 510(k) clearance K861141 for MANUAL OPHTHALMIC SURGICAL INSTRUMENTS, Substantially Equivalent on 1986-04-24. Applicant: CooperVision, Inc..

Clearance details

Applicant: CooperVision, Inc.
Product code: Code HNR
Advisory panel: Ophthalmic
Date received: 1986-03-26
Decision date: 1986-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bellevue, WA, US

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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.