Cleared Traditional

K770428 - VARIOUS SURG. & DIAGNOSTIC INSTRU. ETC.

K770428 is an FDA 510(k) clearance for VARIOUS SURG. & DIAGNOSTIC INSTRU. ETC., manufactured by Holco Instrument Corp.. The device is a Class 1 General & Plastic Surgery device with product code FSM cleared through the Traditional 510(k) pathway after a 919-day FDA review.

K770428 · Holco Instrument Corp. · General & Plastic Surgery device
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Sep 1979
Decision
919d
Days
Class 1
Risk

K770428 is an FDA 510(k) clearance for the VARIOUS SURG. & DIAGNOSTIC INSTRU. ETC.. Classified as Tray, Surgical, Instrument (product code FSM), Class I - General Controls.

Submitted by Holco Instrument Corp. (Mchenry, US). The FDA issued a Cleared decision on September 12, 1979 after a review of 919 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Holco Instrument Corp. devices

FDA 510(k) Submission Details - K770428

510(k) Number K770428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1977
Decision Date September 12, 1979
Days to Decision 919 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
804d slower than avg
Panel avg: 115d · This submission: 919d
Pathway characteristics
Predicate-based equivalence.

FSM Device Classification - Class 1, General Controls

Product Code FSM Tray, Surgical, Instrument
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 - FSM Tray, Surgical, Instrument

All 39
Devices cleared under the same product code (FSM) and FDA review panel - the closest regulatory comparables to K770428.
ADT DISPOSABLE THIN NEEDLE ASPIRATION
K800418 · A.D.T. Lab Industries · Apr 1980
MICRESURGICAL TRAY, SM.,MED., & LG.
K800367 · Edward Weck, Inc. · Mar 1980
WECK RACK (STERILIZING ACCESSORY TRAY)
K791743 · Edward Weck, Inc. · Sep 1979
INSTRUMENT TRAY
K772266 · Med Fusion Systems, Inc. · Jan 1978
ARMOR-KOT SURGICAL INSTRUMENTS
K771680 · Storz Instrument Co. · Nov 1977
SUTURE RACK & NEEDLE COUNTER
K760428 · Kleen Test Products · Nov 1976