HUFFMAN BIOPSY UNIT— 510(k) K873176

Name: FDA 510(k) clearance K873176
Creator: U.S. Food and Drug Administration
Published: 1987-10-14

Substantially Equivalent

Penn Medical Devices, Inc.

FDA 510(k) clearance K873176 for HUFFMAN BIOPSY UNIT, Substantially Equivalent on 1987-10-14. Applicant: Penn Medical Devices, Inc.. Device class: 1.

Clearance details

Applicant: Penn Medical Devices, Inc.
Product code: Code FCL
Device class: Class 1
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 1987-08-12
Decision date: 1987-10-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Basking Ridge, NJ, US

Download summary PDF View on FDA.gov ↗

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More clearances from Penn Medical Devices, Inc.

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K873949 — RORERTAZZI NASOPHARYNGEAL AIRWAY1987-10-20
K873177 — DEVINE (SUPRAPUBIC SOUND AND GUIDE)1987-10-14
K873178 — URETERAL BULB DILATORS1987-09-30
K871667 — URETERAL STENT1987-06-10
K870508 — GASTROINTESTINAL TUBE1987-05-11

Adverse events under product code FCL

product code FCL

Death: 5
Total: 5

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.