VANCE PERCUTANEOUS MALECOT NEPHROSTOMY— 510(k) K810368

Name: FDA 510(k) clearance K810368
Creator: U.S. Food and Drug Administration
Published: 1981-03-20

Substantially Equivalent

Vance Products, Inc.

FDA 510(k) clearance K810368 for VANCE PERCUTANEOUS MALECOT NEPHROSTOMY, Substantially Equivalent on 1981-03-20. Applicant: Vance Products, Inc.. Device class: 2.

Clearance details

Applicant: Vance Products, Inc.
Product code: Code KOB
Device class: Class 2
Regulation: 21 CFR 876.5090
Advisory panel: Gastroenterology, Urology
Date received: 1981-02-12
Decision date: 1981-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KOB

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K240514 — AMT Low-Profile Suprapubic Catheter & Drainage Set2024-11-01
K181097 — Cook Cystostomy Catheter Set2019-01-18
K182709 — One-Step Suprapubic Introducer2018-12-26
K182066 — O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set2018-10-30
K132890 — SUPRAPUBIC CATHETER AND INTRODUCER SET2014-01-17

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

Recalls naming K810368

K-number listed on FDA's recall record

Z-1370-2019 — Cook Salle Intraoperative Pyeloplasty Stent Set PRODUCT/CATALOG NUMBER/GPN: 4.0 Fr - SIPSF-040018-56-6 G18168 4.0 Fr - SIPSF-040018-59 G32773 4.7 Fr SIPSF-050018-59 G32774Class II·Terminated·Cook Inc.·20190422
Z-0968-2020 — Percutaneous Malecot Nephrostomy Set, Global Product No. G16714 G19107 G19108Class II·Terminated·Cook Inc.·20190104
Z-0969-2020 — Percutaneous Pigtail Nephrostomy Set , Global Product No. G14094 G14095 G14899 G14329Class II·Terminated·Cook Inc.·20190104

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K810368.

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