Cleared Traditional

VARIODRAIN

K810636 · Colmed, Ltd. · General & Plastic Surgery
May 1981
Decision
52d
Days
Class 1
Risk

About This 510(k) Submission

K810636 is an FDA 510(k) clearance for the VARIODRAIN, a Apparatus, Suction, Single Patient Use, Portable, Nonpowered (Class I — General Controls, product code GCY), submitted by Colmed, Ltd. (Mchenry, US). The FDA issued a Cleared decision on May 1, 1981, 52 days after receiving the submission on March 10, 1981. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4680.

Submission Details

510(k) Number K810636 FDA.gov
FDA Decision Cleared SESE
Date Received March 10, 1981
Decision Date May 01, 1981
Days to Decision 52 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code GCY — Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4680

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