Cleared Traditional

K955688 - RNS STERILE

K955688 is an FDA 510(k) clearance for RNS STERILE, manufactured by Contour Fabricators of Florida, Inc.. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K955688 · Contour Fabricators of Florida, Inc. · General Hospital
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Feb 1996
Decision
69d
Days
Class 2
Risk

K955688 is an FDA 510(k) clearance for the RNS STERILE, DISPOSABLE STANDARD BIOPSY TRAY. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Contour Fabricators of Florida, Inc. (Palm Harobor, US). The FDA issued a Cleared decision on February 21, 1996 after a review of 69 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 Contour Fabricators of Florida, Inc. devices

FDA 510(k) Submission Details - K955688

510(k) Number K955688 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1995
Decision Date February 21, 1996
Days to Decision 69 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 129d · This submission: 69d
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 125
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K955688.
BIOSHIELD EXPRESS STERILIZATION WRAP
K983719 · Allegiance Healthcare Corp. · Aug 1999
SUPRASHIELD EXPRESS STERILIZATION WRAP
K990300 · Allegiance Healthcare Corp. · Feb 1999
G.E. STERILE, PERCUTANEOUS CHOLANGIOGRAPHIC TRAY
K960204 · GE Medical Systems · Feb 1996
G.E. STERILE, STANDARD BIOPSY TRAY
K960141 · GE Medical Systems · Feb 1996
G.E. STERILE BREAST BIOPSY/LOCALIZATION TRAY
K960201 · GE Medical Systems · Feb 1996
G.E. STERILE PUNCTURE TRAY
K960202 · GE Medical Systems · Feb 1996