Cleared Traditional

SINGLE AND DUAL TOURNIQUET CUFF

K860463 · Aspen Laboratories, Inc. · General & Plastic Surgery
Feb 1986
Decision
19d
Days
Class 1
Risk

About This 510(k) Submission

K860463 is an FDA 510(k) clearance for the SINGLE AND DUAL TOURNIQUET CUFF, a Tourniquet, Pneumatic (Class I — General Controls, product code KCY), submitted by Aspen Laboratories, Inc. (Englewood, US). The FDA issued a Cleared decision on February 25, 1986, 19 days after receiving the submission on February 6, 1986. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.5910.

Submission Details

510(k) Number K860463 FDA.gov
FDA Decision Cleared SESE
Date Received February 06, 1986
Decision Date February 25, 1986
Days to Decision 19 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code KCY — Tourniquet, Pneumatic
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.5910

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