Cleared Traditional

K791984 - SCISSOR'S #'S 2294

K791984 is an FDA 510(k) clearance for SCISSOR'S #'S 2294, manufactured by Edward Weck, Inc.. The device is a Class 1 General & Plastic Surgery device with product code FZT cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K791984 · Edward Weck, Inc. · General & Plastic Surgery device
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Oct 1979
Decision
22d
Days
Class 1
Risk

K791984 is an FDA 510(k) clearance for the SCISSOR'S #'S 2294,2262,2263. 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 17, 1979 after a review of 22 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

FDA 510(k) Submission Details - K791984

510(k) Number K791984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1979
Decision Date October 17, 1979
Days to Decision 22 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
93d faster than avg
Panel avg: 115d · This submission: 22d
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 29
Devices cleared under the same product code (FZT) and FDA review panel - the closest regulatory comparables to K791984.
SCISSORS 6 & 1/2 SHARP/BLUNT
K821124 · Conphar, Inc. · May 1982
OPERATING SCISSORS 5 &1/2 SHARP BLUNT&
K821125 · Conphar, Inc. · May 1982
LISTER BANDAGE SCISSORS 3 & 1/2
K821126 · Conphar, Inc. · May 1982
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