JAMES SURGICAL SYSTEM J1000— 510(k) K890195

Substantially Equivalent

O.R. Specialties, Inc.

FDA 510(k) clearance K890195 for JAMES SURGICAL SYSTEM J1000, Substantially Equivalent on 1989-08-03. Applicant: O.R. Specialties, Inc..

Clearance details

Applicant: O.R. Specialties, Inc.
Product code: Code HQE
Advisory panel: Ophthalmic
Date received: 1989-01-18
Decision date: 1989-08-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tuscaloosa, AL, US

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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.