Cleared Traditional

K941645 - BIOPSY TRAY

K941645 is an FDA 510(k) clearance for BIOPSY TRAY, manufactured by Cush Medical Products. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K941645 · Cush Medical Products · General Hospital
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Jul 1994
Decision
101d
Days
Class 2
Risk

K941645 is an FDA 510(k) clearance for the BIOPSY TRAY. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Cush Medical Products (Piney Flats, US). The FDA issued a Cleared decision on July 14, 1994 after a review of 101 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 Cush Medical Products devices

FDA 510(k) Submission Details - K941645

510(k) Number K941645 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received April 04, 1994
Decision Date July 14, 1994
Days to Decision 101 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 129d · This submission: 101d
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 147
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K941645.
STERIMED STERIZATION WRAPPER (NON-STERILE)
K953678 · Customed, Inc. · Oct 1995
SAFEDWEEL DRESSING CHANGE TRAY
K950438 · Becton Dickinson Vascular Access, Inc. · Mar 1995
MAMMOCORE BIOPSY TRAY
K943653 · Manan Medical Products, Inc. · Jan 1995
ARGYLE TURKEL SAFETY PARACENTESIS PROCEDURE TRAY
K935238 · Sherwood Medical Co. · Feb 1994
INCISION/DRAINAGE TRAY
K935681 · Cush Medical Products · Feb 1994
LACERATION TRAY
K935682 · Cush Medical Products · Feb 1994