STABILTRACH— 510(k) K935171

Name: FDA 510(k) clearance K935171
Creator: U.S. Food and Drug Administration
Published: 1993-12-02

Substantially Equivalent

B&B Medical Technologies, Inc.

FDA 510(k) clearance K935171 for STABILTRACH, Substantially Equivalent on 1993-12-02. Applicant: B&B Medical Technologies, Inc.. Device class: 1.

Clearance details

Applicant: B&B Medical Technologies, Inc.
Product code: Code CBH
Device class: Class 1
Regulation: 21 CFR 868.5770
Advisory panel: Anesthesiology
Date received: 1993-10-26
Decision date: 1993-12-02
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 CBH

product code CBH

Death: 7
Total: 7

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.