VNACE FASCIAL DILATOR SET— 510(k) K811833

Substantially Equivalent

Vance Products, Inc.

FDA 510(k) clearance K811833 for VNACE FASCIAL DILATOR SET, Substantially Equivalent on 1981-07-10. Applicant: Vance Products, Inc.. Device class: 2.

Clearance details

Applicant: Vance Products, Inc.
Product code: Code KOE
Device class: Class 2
Regulation: 21 CFR 876.5520
Advisory panel: Gastroenterology, Urology
Date received: 1981-06-30
Decision date: 1981-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KOE

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K972964 — ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE1997-10-10
K962611 — BARD EAGLE INFLATION DEVICE1996-10-21
K961904 — AQ HYDROPHILIC DILATORS1996-10-18

More clearances from Vance Products, Inc.

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

Recalls naming K811833

K-number listed on FDA's recall record

Z-0971-2020 — Urethral Dilator Set, Global Product No. G14185Class II·Terminated·Cook Inc.·20190104

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K811833.

Data sourced from openFDA. This site is unofficial and independent of the FDA.