GLENOID DRILL— 510(k) K863147

Name: FDA 510(k) clearance K863147
Creator: U.S. Food and Drug Administration
Published: 1986-09-05

Substantially Equivalent

Bowen & Company, Inc.

FDA 510(k) clearance K863147 for GLENOID DRILL, Substantially Equivalent on 1986-09-05. Applicant: Bowen & Company, Inc.. Device class: 1.

Clearance details

Applicant: Bowen & Company, Inc.
Product code: Code HTW
Device class: Class 1
Regulation: 21 CFR 888.4540
Advisory panel: Orthopedic
Date received: 1986-08-15
Decision date: 1986-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockville, MD, US

Download summary PDF View on FDA.gov ↗

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More clearances from Bowen & Company, Inc.

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K896898 — BOWEN ELECTRODE SKIN PREPATORY CLEANSER1990-04-04
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K873766 — STERNAL POWER AWL1988-11-14
K872098 — CREMEEN ALVEOLAR BONE CALIPER1987-07-31
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Adverse events under product code HTW

product code HTW

Injury: 882
Malfunction: 8,544
Other: 3
Total: 9,429

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.