POLYETHYLENE TEREPHTHALATE (PET) PLEDGET— 510(k) K953425

Substantially Equivalent

Davis & Geck, Inc.

FDA 510(k) clearance K953425 for POLYETHYLENE TEREPHTHALATE (PET) PLEDGET, Substantially Equivalent on 1995-08-21. Applicant: Davis & Geck, Inc..

Clearance details

Applicant: Davis & Geck, Inc.
Product code: Code DXZ
Advisory panel: Cardiovascular
Date received: 1995-07-21
Decision date: 1995-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danbury, CT, US

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Adverse events under product code DXZ

product code DXZ

Death: 19
Injury: 265
Total: 284

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.