SOLOS, CIDEO CAMERA REPLACEMENT CABLE, 800/900 SERIES— 510(k) K970056

Substantially Equivalent

Woodbine Optical Corp.

FDA 510(k) clearance K970056 for SOLOS, CIDEO CAMERA REPLACEMENT CABLE, 800/900 SERIES, Substantially Equivalent on 1997-01-28. Applicant: Woodbine Optical Corp..

Clearance details

Applicant: Woodbine Optical Corp.
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 1997-01-07
Decision date: 1997-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Braintree, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GCJ

product code GCJ

Death: 39
Injury: 1,638
Malfunction: 28,216
Other: 11
Total: 29,904

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.