Cleared Traditional

K770428 - VARIOUS SURG. & DIAGNOSTIC INSTRU. ETC. (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

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

Submission Details

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
805d slower than avg
Panel avg: 114d · This submission: 919d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.