Surgical Loops

FDA 510(k) K812389 · Berkeley Medevices

Substantially Equivalent

510(k) numberK812389

Submission

Device name
Surgical Loops
Applicant
Berkeley Medevices
Mchenry, IL, US
Received
August 20, 1981
Decision date
November 16, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GAD – Retractor
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Specialty
General, Plastic Surgery

Other 510(k)s with product code GAD

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K152538JRP Wound SpreaderGAD · Traditional J.R. Parker, LLC04/13/2016SE
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K132645Thoratrak Mics Retractor System, Rack, BladesGAD · Traditional Medtronic, Inc.10/04/2013SE
K071775DashGAD · Traditional Ezsurgical08/07/2007SE
K050256Apple Medical/Ob Mobius Elastic RetractorGAD · Traditional Apple Medical Corp.04/26/2005SE
K043602Quadrant Retractor SystemGAD · Traditional Medtronic Sofamor Danek02/23/2005SE
K001339MRI Fastsystem Retractor SystemGAD · Special Omni-Tract Surgical, Div. Minn. Scientific, Inc.05/17/2000SE
K980588Clarus Endoscopic Discectomy System Sitetrac Model 6000GAD · Traditional Clarus Medical Systems, Inc.08/18/1998SE
K963006Scion Saphenous Vein Harvesting SystemGAD · Traditional Scion International, Inc.09/20/1996SE
K943875Villalta RetractorGAD · Traditional Hct, Inc.11/09/1994SE

More from Hct, Inc.

510(k)DeviceDecision
K892220Laminaria TentHDY · Traditional 06/14/1989SE
K840952Medevice V-80 Vacuum PumpHHI · Traditional 03/30/1984SE
K823006Medevices Aspiration HoseHHK · Traditional 11/04/1982SE
K812388Surgical PawsGDJ · Traditional 11/16/1981SE

Questions and answers

When was Surgical Loops cleared by the FDA?

Surgical Loops (K812389) received a 510(k) decision of Substantially Equivalent on November 16, 1981, 88 days after the submission was received.

What is the product code of K812389?

The FDA product code is GAD – Retractor, a Class I (low risk) device regulated under 21 CFR 878.4800.