DEGANIA SILICONE INDENTI LOOPS— 510(k) K964547

Substantially Equivalent

Degania Silicone , Ltd.

FDA 510(k) clearance K964547 for DEGANIA SILICONE INDENTI LOOPS, Substantially Equivalent on 1997-01-08. Applicant: Degania Silicone , Ltd..

Clearance details

Applicant: Degania Silicone , Ltd.
Product code: Code DXC
Advisory panel: Cardiovascular
Date received: 1996-11-13
Decision date: 1997-01-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Emek Hayarden, IL

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Adverse events under product code DXC

product code DXC

Death: 14
Injury: 442
Malfunction: 2,209
Other: 1
Total: 2,666

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.