Cleared Traditional

K790684 - COLOR CODING OF SURGICAL INSTRUMENTS

K790684 is an FDA 510(k) clearance for COLOR CODING OF SURGICAL INSTRUMENTS, manufactured by Sara Dan, Inc.. The device is a Class 1 General & Plastic Surgery device with product code FZT cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K790684 · Sara Dan, Inc. · General & Plastic Surgery device
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May 1979
Decision
37d
Days
Class 1
Risk

K790684 is an FDA 510(k) clearance for the COLOR CODING OF SURGICAL INSTRUMENTS. Classified as Cutter, Surgical (product code FZT), Class I - General Controls.

Submitted by Sara Dan, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 18, 1979 after a review of 37 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 Sara Dan, Inc. devices

FDA 510(k) Submission Details - K790684

510(k) Number K790684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 1979
Decision Date May 18, 1979
Days to Decision 37 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
78d faster than avg
Panel avg: 115d · This submission: 37d
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 K790684.
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
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