VANCE PROSTATIC ASPIRATION SET— 510(k) K811454

Name: FDA 510(k) clearance K811454
Creator: U.S. Food and Drug Administration
Published: 1981-06-09

Substantially Equivalent

Vance Products, Inc.

FDA 510(k) clearance K811454 for VANCE PROSTATIC ASPIRATION SET, Substantially Equivalent on 1981-06-09. Applicant: Vance Products, Inc.. Device class: 2.

Clearance details

Applicant: Vance Products, Inc.
Product code: Code KNW
Device class: Class 2
Regulation: 21 CFR 876.1075
Advisory panel: Gastroenterology, Urology
Date received: 1981-05-22
Decision date: 1981-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KNW

view all

K260517 — Automatic Core Biopsy Instrument2026-08-28
K262571 — EnCor EnCompass Breast Biopsy and Tissue Removal System2026-08-14
K262792 — Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)2026-08-12
K260572 — Marrow Marxman2026-08-04
K261196 — Promisemed VeriEcto Automatic Biopsy Needles2026-05-12

More clearances from Vance Products, Inc.

view all

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 KNW

product code KNW

Death: 9
Injury: 965
Malfunction: 10,444
Other: 3
Total: 11,421

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.