Cleared Traditional

STRAITH DRAIN INSERTER

K840835 · Surgical Technology Laboratories, Inc. · General & Plastic Surgery
Apr 1984
Decision
59d
Days
Class 1
Risk

About This 510(k) Submission

K840835 is an FDA 510(k) clearance for the STRAITH DRAIN INSERTER, a Guide, Surgical, Instrument (Class I — General Controls, product code FZX), submitted by Surgical Technology Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 23, 1984, 59 days after receiving the submission on February 24, 1984. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4800.

Submission Details

510(k) Number K840835 FDA.gov
FDA Decision Cleared SESE
Date Received February 24, 1984
Decision Date April 23, 1984
Days to Decision 59 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code FZX — Guide, Surgical, Instrument
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4800

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