Operating Room Tray

FDA 510(k) K860160 · Medical Design Concepts, Inc.

Substantially Equivalent

510(k) numberK860160

Submission

Device name
Operating Room Tray
Applicant
Medical Design Concepts, Inc.
Carlsbad, CA, US
Received
January 16, 1986
Decision date
February 27, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

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

Other 510(k)s with product code FSM

510(k)DeviceApplicantDecision
K971217Instrument Tray LinerFSM · Traditional General Hospital Supply Corp.05/06/1997SE
K962328Single Use Instrument TrayFSM · Traditional Medcare Medical Group, Inc.08/09/1996SE
K944025Surgical Instrument TrayFSM · Traditional Riley Medical, Inc.11/22/1994SE
K912106Arthroscopy TrayFSM · Traditional Medical Device Inspection Co., Inc.08/29/1991SE
K912053Open Heart TrayFSM · Traditional Medical Device Inspection Co., Inc.08/26/1991SE
K912052Heart Cath TrayFSM · Traditional Medical Device Inspection Co., Inc.08/20/1991SE
K912104Major Basin TrayFSM · Traditional Medical Device Inspection Co., Inc.08/09/1991SE
K910570Splinter TweezersFSM · Traditional Solan Scissors Sales05/31/1991SE
K911601Reddick Trocar and CannulaFSM · Traditional Ideal Medical, Inc.05/21/1991SE
K910328Key Comfort GripsFSM · Traditional Key Surgical, Inc.03/06/1991SE

More from Key Surgical, Inc.

510(k)DeviceDecision
K860161Heart Catheterization TrayDRE · Traditional 05/02/1986SE

Questions and answers

When was Operating Room Tray cleared by the FDA?

Operating Room Tray (K860160) received a 510(k) decision of Substantially Equivalent on February 27, 1986, 42 days after the submission was received.

What is the product code of K860160?

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