RESUBMITTED JUNIPER T.M. JOINT DISTRACTION FORCEPS— 510(k) K881757

Substantially Equivalent

Downs Surgical , Ltd.

FDA 510(k) clearance K881757 for RESUBMITTED JUNIPER T.M. JOINT DISTRACTION FORCEPS, Substantially Equivalent on 1988-07-15. Applicant: Downs Surgical , Ltd..

Clearance details

Applicant: Downs Surgical , Ltd.
Product code: Code ETN
Advisory panel: Ear, Nose, Throat
Date received: 1988-04-25
Decision date: 1988-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, MA, US

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Adverse events under product code ETN

product code ETN

Death: 7
Injury: 327
Malfunction: 2,776
Total: 3,110

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.