PENLON CIRCLE SYSTEM— 510(k) K864588

Substantially Equivalent

Bear Medical Systems, Inc.

FDA 510(k) clearance K864588 for PENLON CIRCLE SYSTEM, Substantially Equivalent on 1987-02-03. Applicant: Bear Medical Systems, Inc..

Clearance details

Applicant: Bear Medical Systems, Inc.
Product code: Code CAI
Advisory panel: Anesthesiology
Date received: 1986-11-21
Decision date: 1987-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Riverside, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CAI

product code CAI

Malfunction: 869
Other: 1
Total: 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.