VANCE DEFLECTABLE BIOPSY BRUSH SET— 510(k) K810372

Name: FDA 510(k) clearance K810372
Creator: U.S. Food and Drug Administration
Published: 1981-03-20

Substantially Equivalent

Vance Products, Inc.

FDA 510(k) clearance K810372 for VANCE DEFLECTABLE BIOPSY BRUSH SET, Substantially Equivalent on 1981-03-20. Applicant: Vance Products, Inc.. Device class: 2.

Clearance details

Applicant: Vance Products, Inc.
Product code: Code KOD
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1981-02-12
Decision date: 1981-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Vance Products, Inc.

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K812995 — VANCE-JACOBELLIS MICROHEMATURIA CATHETER1982-03-01
K820313 — VPI-FAIR URETHRAL STENT1982-03-01
K813278 — VPI URETERAL DILATATION BALLON CATHETER1981-12-18
K812785 — VANCE-AMBROSE RESECTOSCOPE FORCEPS1981-11-16
K812057 — VANCE CYSTOSCOPIC1981-07-31

Adverse events under product code KOD

product code KOD

Death: 5
Injury: 1,129
Malfunction: 7,019
Total: 8,153

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.