Cleared Traditional

LASCHAL SCISSOR (K780575) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K780575 · Laschal Instrument Corp. · General & Plastic Surgery device
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Apr 1978
Decision
8d
Days
Class 1
Risk

K780575 is an FDA 510(k) clearance for the LASCHAL SCISSOR. Classified as Cutter, Surgical (product code FZT), Class I - General Controls.

Submitted by Laschal Instrument Corp. (Mchenry, US). The FDA issued a Cleared decision on April 18, 1978 after a review of 8 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 Laschal Instrument Corp. devices

Submission Details

510(k) Number K780575 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1978
Decision Date April 18, 1978
Days to Decision 8 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
107d faster than avg
Panel avg: 115d · This submission: 8d
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 K780575.
FLOOR LINE INSTRUMENTS
K791741 · Edward Weck, Inc. · Oct 1979
BROOKS GALL BLADDER SCISSORS (SURG)
K791742 · Edward Weck, Inc. · Oct 1979
SURGICAL INSTRUMENTS HEIFETZ DIGITATE
K791734 · Edward Weck, Inc. · Sep 1979
FACELIFT SCISSORS
K780152 · Edward Weck, Inc. · Feb 1978
SURG. SCISSORS FOR CUTTING TISSUE
K771743 · Depuy, Inc. · Sep 1977