Cleared Traditional

K834142 - ADHESIVE TRACTION TAPE

K834142 is an FDA 510(k) clearance for ADHESIVE TRACTION TAPE, manufactured by Devon Industries, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GAD cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K834142 · Devon Industries, Inc. · General & Plastic Surgery device
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Apr 1984
Decision
144d
Days
Class 1
Risk

K834142 is an FDA 510(k) clearance for the ADHESIVE TRACTION TAPE. Classified as Retractor (product code GAD), Class I - General Controls.

Submitted by Devon Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 23, 1984 after a review of 144 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Devon Industries, Inc. devices

FDA 510(k) Submission Details - K834142

510(k) Number K834142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1983
Decision Date April 23, 1984
Days to Decision 144 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 115d · This submission: 144d
Pathway characteristics
Predicate-based equivalence.

GAD Device Classification - Class 1, General Controls

Product Code GAD Retractor
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GAD Retractor

All 39
Devices cleared under the same product code (GAD) and FDA review panel - the closest regulatory comparables to K834142.
FINOCCHIETO RIB RETRACTOR 1711-72 PCS. SS 303, 420
K851115 · The Huxley Instrument Corp. · Apr 1985
INSTRUMENTS FOR MICRO ANASTOMOSIS
K843100 · Downs Surgical , Ltd. · Sep 1984
SURGICAL RETRACTORS-VARIOUS
K841009 · Premier Dental Products Co. · May 1984
FLEXI-TY
K832765 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1984
H.R. JAKOBI SURG. INSTRUMENTS #11 16/46
K834181 · Imm Enterprises , Ltd. · Jan 1984
JAKOBI SURG. INSTRUMENTS #11 20/25/27/37
K834196 · Imm Enterprises , Ltd. · Jan 1984