SUCTION-OFF— 510(k) K863653

Name: FDA 510(k) clearance K863653
Creator: U.S. Food and Drug Administration
Published: 1986-10-07

Substantially Equivalent

B&B Medical Technologies, Inc.

FDA 510(k) clearance K863653 for SUCTION-OFF, Substantially Equivalent on 1986-10-07. Applicant: B&B Medical Technologies, Inc.. Device class: 1.

Clearance details

Applicant: B&B Medical Technologies, Inc.
Product code: Code HXD
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1986-09-18
Decision date: 1986-10-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orangevale, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HXD

product code HXD

Malfunction: 660
Total: 660

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.