Mityvac Merlin, Model 10027

FDA 510(k) K020447 · Prism Enterprises, Inc.

Substantially Equivalent

510(k) numberK020447

Submission

Device name
Mityvac Merlin, Model 10027
Applicant
Prism Enterprises, Inc.
Washington, DC, US
Received
February 11, 2002
Decision date
April 12, 2002
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HDB – Extractor, Vacuum, Fetal
Device class
Class II (moderate risk)
Regulation
21 CFR 884.4340
Specialty
Obstetrics/Gynecology

Other 510(k)s with product code HDB

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K250298Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M); Kiwi® Complete Vacuum…HDB · Traditional Clinical Innovations, LLC10/08/2025SE
K041579Medela Single Use Silc Cup, Model 077.0791HDB · Traditional Medela AG04/21/2005SE
K043614Vaculink, Model VCL 3000HDB · Traditional Medevco, Inc.04/14/2005SE
K021193Fortune Silicone Vacuum Suction, Model #1300HDB · Traditional Fortune Medical Instrument Corp.02/12/2003SE
K013460Swift Low Profile Cup (Pro Cup)HDB · Traditional Swift Delivery Products01/17/2002SE
K011532MityvacHDB · Special Prism Enterprises, Inc.07/30/2001SE
K981260Kiwi Soft Cup with Palm Pump Model Number VFE-6000S, Kiwi Mushroom Cup with Palm Pump…HDB · Traditional Clinical Innovations, Inc.09/22/1998SE
K980976Ameda Disposable Vacuum Assist Cup with Fluid Retention TrapHDB · Traditional Hollister, Inc.08/21/1998SE
K980212MityvacHDB · Traditional Prism Technologies, Inc.07/09/1998SE
K973942Swift Delivery Product #300HDB · Traditional Swift Delivery Products12/12/1997SE

More from Swift Delivery Products

510(k)DeviceDecision
K030283Baby PodFPP · Traditional 04/22/2003SE
K011532MityvacHDB · Special 07/30/2001SE
K000444Mityview 4-WAY Lateral Expander SpeculumHIB · Traditional 04/21/2000SE

Questions and answers

When was Mityvac Merlin, Model 10027 cleared by the FDA?

Mityvac Merlin, Model 10027 (K020447) received a 510(k) decision of Substantially Equivalent on April 12, 2002, 60 days after the submission was received.

What is the product code of K020447?

The FDA product code is HDB – Extractor, Vacuum, Fetal, a Class II (moderate risk) device regulated under 21 CFR 884.4340.