Cleared Traditional

K990761 - TUTTNAUER MINI CONTAINER CASSETTE, TUTTNAUER STANDARD CASE CASSETTE

K990761 is an FDA 510(k) clearance for TUTTNAUER MINI CONTAINER CASSETTE, manufactured by Tuttnauer U.S.A Co, Ltd.. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 123-day FDA review.

K990761 · Tuttnauer U.S.A Co, Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
123d
Days
Class 2
Risk

K990761 is an FDA 510(k) clearance for the TUTTNAUER MINI CONTAINER CASSETTE, TUTTNAUER STANDARD CASE CASSETTE. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Tuttnauer U.S.A Co, Ltd. (Washington D.C., US). The FDA issued a Cleared decision on July 9, 1999 after a review of 123 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Tuttnauer U.S.A Co, Ltd. devices

FDA 510(k) Submission Details - K990761

510(k) Number K990761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1999
Decision Date July 09, 1999
Days to Decision 123 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 129d · This submission: 123d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRG Device Classification - Class 2, Special Controls

Product Code FRG Wrap, Sterilization
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 - FRG Wrap, Sterilization

All 244
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K990761.
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GLOBAL HEALTHCARE SELF-SEALING STERILIZATION POUCH
K990567 · Global Healthcare, Inc. · Apr 1999
SUPRASHIELD EXPRESS STERILIZATION WRAP
K990300 · Allegiance Healthcare Corp. · Feb 1999
DENTAL STERLIZATION TRAY/CASSETTE
K983223 · Brasseler USA I, L.P. · Jan 1999