RICA(TM)-RING INTEST. COMPRESS. STAPLE ANASTOM KIT— 510(k) K873748

Substantially Equivalent

Deknatel, Inc.

FDA 510(k) clearance K873748 for RICA(TM)-RING INTEST. COMPRESS. STAPLE ANASTOM KIT, Substantially Equivalent on 1988-01-06. Applicant: Deknatel, Inc..

Clearance details

Applicant: Deknatel, Inc.
Product code: Code GDW
Advisory panel: General, Plastic Surgery
Date received: 1987-09-16
Decision date: 1988-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Success, NY, US

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Adverse events under product code GDW

product code GDW

Death: 450
Injury: 12,684
Malfunction: 68,730
Other: 6
Total: 81,870

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.