ADDITIVE HINGE CAP— 510(k) K791796

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K791796 for ADDITIVE HINGE CAP, Substantially Equivalent on 1979-10-01. Applicant: Abbott Laboratories.

Clearance details

Applicant: Abbott Laboratories
Product code: Code KPE
Advisory panel: General Hospital
Date received: 1979-09-14
Decision date: 1979-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KPE

product code KPE

Malfunction: 1,000
Other: 1
Total: 1,001

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.