FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

MEDLINE SHARPS CONTAINER

K Number: K132767 · Decision Feb 3, 2014
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
112
Applicant Total
238
Review Days
152

Research this 510(k) in seconds

The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

Free to try · every answer cites its records

Basic Information

Device Name
MEDLINE SHARPS CONTAINER
K Number
K132767
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
880.5570
Medical Specialty
General Hospital
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Medline Industries, Inc.
Date Received
September 4, 2013
Decision Date
February 3, 2014
Product Code
MMK
Advisory Committee
General Hospital
Review Advisory Committee
HO
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
MMK Container, Sharps

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (MMK), ordered by most recent decision date.

View all

Other Clearances by Medline Industries, Inc.

K Number Device Name
DEN210049 Medline ART Skin Harvesting System
K230559 Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260)
K223100 Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14)
K222665 Medline UNITE® Ankle Fusion Plating System
K213054 Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe
K212911 Konig Mogen Clamp
K220565 Hudson RCI Triflo II Incentive Deep Breathing Exerciser
K213481 Medline General Surgery Tray
K212093 Medline Universal Grounding Pad
K213068 Medline Smoke Evacuation Shroud
Search all 238 clearances from Medline Industries, Inc. →