Skytron Elite Surgical Tables

FDA 510(k) K811311 · Skytron, Div. the Kmw Group, Inc.

Substantially Equivalent

510(k) numberK811311

Submission

Device name
Skytron Elite Surgical Tables
Applicant
Skytron, Div. the Kmw Group, Inc.
Mchenry, IL, US
Received
May 11, 1981
Decision date
June 2, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GBC – Lamp, Surgical, Incandescent
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4580
Specialty
General, Plastic Surgery

Other 510(k)s with product code GBC

510(k)DeviceApplicantDecision
K896961Halux Exlite Minor Surgery LightGBC · Traditional Jedmed Instrument Co.02/22/1990SE
K830610Flat Suction DrainGBC · Traditional Sil-Med Corp.03/29/1983SE
K810207Minor Surgery LightGBC · Traditional Cavitron Corp.02/13/1981SE

More from Cavitron Corp.

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K950192Skytron Skyboom SeriesFQO · Traditional 04/03/1995SE
K940616Skytron Elite 3500 TableGDC · Traditional 06/13/1994SE
K933564Skytron Exam LightKZF · Traditional 02/10/1994SE
K926045Skytron Life Island 21FNM · Traditional 07/27/1993SE
K915285Skytron Infinity Series Surgical LightsFSY · Traditional 02/20/1992SE
K900472Skytron Model 860 and 800 Comp. Surgita Neuro EquiHBN · Traditional 09/04/1990SE

Questions and answers

When was Skytron Elite Surgical Tables cleared by the FDA?

Skytron Elite Surgical Tables (K811311) received a 510(k) decision of Substantially Equivalent on June 2, 1981, 22 days after the submission was received.

What is the product code of K811311?

The FDA product code is GBC – Lamp, Surgical, Incandescent, a Class II (moderate risk) device regulated under 21 CFR 878.4580.