Cleared Traditional

K770590 - SURGI-KIT

K770590 is the FDA 510(k) clearance for SURGI-KIT by Ethox Corp.. It is a Class 2 General Hospital device (product code KCT) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K770590 · Ethox Corp. · General Hospital
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Apr 1977
Decision
17d
Days
Class 2
Risk

K770590 is an FDA 510(k) clearance for the SURGI-KIT. Classified as Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (product code KCT), Class II - Special Controls.

Submitted by Ethox Corp. (Mchenry, US). The FDA issued a Cleared decision on April 14, 1977 after a review of 17 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - the FDA general hospital 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 Ethox Corp. devices

Submission Details

510(k) Number K770590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1977
Decision Date April 14, 1977
Days to Decision 17 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 129d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6850
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

All 163
Devices cleared under the same product code (KCT) and FDA review panel - the closest regulatory comparables to K770590.
EAGLE PAC/VISIBLE SEAL
K781699 · American Sterilizer Co. · Oct 1978
SURGICAL INSTRUMENT PROTECTOR
K771123 · Devon Industries, Inc. · Oct 1977
INSTRUMENT TRAY PAD
K771124 · Devon Industries, Inc. · Oct 1977
PROTECTOR, SURGICAL INSTRUMENT
K760320 · Devon Industries, Inc. · Sep 1976