Cleared Traditional

SUTURE REMOVAL PAK (K801746) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K801746 · Devco Medical Industries, Inc. · General & Plastic Surgery device
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Aug 1980
Decision
23d
Days
Class 1
Risk

K801746 is an FDA 510(k) clearance for the SUTURE REMOVAL PAK. Classified as Cutter, Surgical (product code FZT), Class I - General Controls.

Submitted by Devco Medical Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 20, 1980 after a review of 23 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Devco Medical Industries, Inc. devices

Submission Details

510(k) Number K801746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1980
Decision Date August 20, 1980
Days to Decision 23 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 115d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FZT Cutter, Surgical
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 - FZT Cutter, Surgical

All 29
Devices cleared under the same product code (FZT) and FDA review panel - the closest regulatory comparables to K801746.
SCISSORS 6 & 1/2 SHARP/BLUNT
K821124 · Conphar, Inc. · May 1982
OPERATING SCISSORS 5 &1/2 SHARP BLUNT&
K821125 · Conphar, Inc. · May 1982
LISTER BANDAGE SCISSORS 3 & 1/2
K821126 · Conphar, Inc. · May 1982
SCISSOR'S #'S 2294,2262,2263
K791984 · Edward Weck, Inc. · Oct 1979
FLOOR LINE INSTRUMENTS
K791741 · Edward Weck, Inc. · Oct 1979
BROOKS GALL BLADDER SCISSORS (SURG)
K791742 · Edward Weck, Inc. · Oct 1979