Cleared Traditional

FLOOR LINE INSTRUMENTS (K791741) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K791741 · Edward Weck, Inc. · General & Plastic Surgery device
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Oct 1979
Decision
24d
Days
Class 1
Risk

K791741 is an FDA 510(k) clearance for the FLOOR LINE INSTRUMENTS. Classified as Cutter, Surgical (product code FZT), Class I - General Controls.

Submitted by Edward Weck, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 4, 1979 after a review of 24 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 Edward Weck, Inc. devices

Submission Details

510(k) Number K791741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 1979
Decision Date October 04, 1979
Days to Decision 24 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 115d · This submission: 24d
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 7
Devices cleared under the same product code (FZT) and FDA review panel - the closest regulatory comparables to K791741.
AUTO SUTURE DISPOSABLE SURGICAL TROCAR*
K890818 · United States Surgical, A Division of Tyco Healthc · May 1989
SURGICAL SCISSORS, SET OF 3
K821632 · Fred Sammons, Inc. · Jun 1982
SCISSOR'S #'S 2294,2262,2263
K791984 · 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