SMITH & NEPHEW IMAGES ARTHROSCOPE/ENT ENDOSCOPE— 510(k) K970247

Substantially Equivalent

Smith & Nephew, Inc.

FDA 510(k) clearance K970247 for SMITH & NEPHEW IMAGES ARTHROSCOPE/ENT ENDOSCOPE, Substantially Equivalent on 1997-03-21. Applicant: Smith & Nephew, Inc..

Clearance details

Applicant: Smith & Nephew, Inc.
Product code: Code EOB
Advisory panel: Ear, Nose, Throat
Date received: 1997-01-22
Decision date: 1997-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Andover, MA, US

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Adverse events under product code EOB

product code EOB

Malfunction: 6,143
Total: 6,143

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.