Olsen #770 Disposable Holster

FDA 510(k) K820158 · Olsen Electro-Surgical Instruments, Inc.

Substantially Equivalent

510(k) numberK820158

Submission

Device name
Olsen #770 Disposable Holster
Applicant
Olsen Electro-Surgical Instruments, Inc.
Anaheim, CA, US
Received
January 20, 1982
Decision date
February 5, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KDC – Instrument, Surgical, Disposable
Device class
Class I (low risk)
Regulation
21 CFR 878.4800
Specialty
General, Plastic Surgery

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K943229Disposable Surgical Scissors and ForcepsKDC · Traditional Y.M.K. International Co., Ltd.08/19/1994SE
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K920153Thermuff BagKDC · Traditional Techstyles07/01/1992SE
K920263Manual Surgical InstrumentsKDC · Traditional Phoenix Instruments Div.05/06/1992SE
K915064Disposable Cautery Abrasive PadKDC · Traditional American Medical Mfg., Inc.03/11/1992SE
K914960Instrument OrganizerKDC · Traditional O.R. Concepts, Inc.02/28/1992SE
K912834Shur-GripKDC · Traditional Inman Medical Corp.07/26/1991SE
K910079Disposable Introducer SheathKDC · Traditional Applied Vascular Devices, Inc.02/27/1991SE
K905240VesseloopsKDC · Traditional Sparta Surgical Corp.02/06/1991SE
K903649Bradley Tenaculum HolderKDC · Traditional Marlo Surgical Technology11/02/1990SE

More from Marlo Surgical Technology

510(k)DeviceDecision
K834410Double-Coagulation Switchpen 757GEI · Traditional 04/04/1984SE
K834329Olsen 756 Rocker SwitchpenGEI · Traditional 04/04/1984SE

Questions and answers

When was Olsen #770 Disposable Holster cleared by the FDA?

Olsen #770 Disposable Holster (K820158) received a 510(k) decision of Substantially Equivalent on February 5, 1982, 16 days after the submission was received.

What is the product code of K820158?

The FDA product code is KDC – Instrument, Surgical, Disposable, a Class I (low risk) device regulated under 21 CFR 878.4800.