Cleared Traditional

K780574 - SUTURE CUTTER

K780574 is an FDA 510(k) clearance for SUTURE CUTTER, manufactured by Laschal Instrument Corp.. The device is a Class 1 General & Plastic Surgery device with product code FZT cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K780574 · Laschal Instrument Corp. · General & Plastic Surgery device
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Jul 1978
Decision
98d
Days
Class 1
Risk

K780574 is an FDA 510(k) clearance for the SUTURE CUTTER. 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 July 17, 1978 after a review of 98 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 Laschal Instrument Corp. devices

FDA 510(k) Submission Details - K780574

510(k) Number K780574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1978
Decision Date July 17, 1978
Days to Decision 98 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
17d faster than avg
Panel avg: 115d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

FZT Device Classification - Class 1, General Controls

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 35
Devices cleared under the same product code (FZT) and FDA review panel - the closest regulatory comparables to K780574.
BROOKS GALL BLADDER SCISSORS (SURG)
K791742 · Edward Weck, Inc. · Oct 1979
SURGICAL INSTRUMENTS HEIFETZ DIGITATE
K791734 · Edward Weck, Inc. · Sep 1979
ITIMIZED INSTRUMENTS
K790491 · E.M. Adams · Apr 1979
FACELIFT SCISSORS
K780152 · Edward Weck, Inc. · Feb 1978
LAPAROSCOPY DRAPE, BOUNDARY
K772301 · Procter & Gamble Mfg. Co. · Dec 1977
THOREK SCISSORS 7 1/4 & 10
K771806 · J. Sklar Mfg. Co., Inc. · Oct 1977