FINGER TOURNIQUETTE— 510(k) K853472

Substantially Equivalent

Joseph B. Marogil

FDA 510(k) clearance K853472 for FINGER TOURNIQUETTE, Substantially Equivalent on 1985-10-10. Applicant: Joseph B. Marogil. Device class: 1.

Clearance details

Applicant: Joseph B. Marogil
Product code: Code GAX
Device class: Class 1
Regulation: 21 CFR 878.5900
Advisory panel: General, Plastic Surgery
Date received: 1985-08-20
Decision date: 1985-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grand Rapids, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GAX

K931198 — UNIQUET1993-09-01
K881398 — TOURNIQUET1988-04-29
K881176 — STERILE ESMARCH BANDAGE1988-04-11
K875092 — DEGANIA SILICONE TOURNIQUET1988-01-07
K873928 — UNIVERSAL TOURNIQUET1987-10-23

Recalls naming K853472

K-number listed on FDA's recall record

Z-0945-2021 — Tourni-Cot - Universal, UDI 00855364004085, Model Number TCU, Non-pneumatic Tourniquet - Product Usage: The device is intended to be used in surgery on fingers or toes to provide a blood-less field.Class II·Terminated·Mar-Med Co·20201228

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K853472.

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