STEPHENS DISPOSABLE FORCEPS— 510(k) K022835

Substantially Equivalent

Stephens Instruments

FDA 510(k) clearance K022835 for STEPHENS DISPOSABLE FORCEPS, Substantially Equivalent on 2002-11-01. Applicant: Stephens Instruments.

Clearance details

Applicant: Stephens Instruments
Product code: Code HNR
Advisory panel: Ophthalmic
Date received: 2002-08-27
Decision date: 2002-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lexington, KY, 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.