Instrument Sterilization Tray

FDA 510(k) K863726 · Medical Technology Development Corp.

Substantially Equivalent

510(k) numberK863726

Submission

Device name
Instrument Sterilization Tray
Applicant
Medical Technology Development Corp.
Clearwater, FL, US
Received
September 23, 1986
Decision date
October 14, 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
K941488Devmed Double-Balloon Urological CatheterEZL · Traditional 11/30/1994SE
K862315Fyodorov Collagen Corneal ShieldMOE · Traditional 01/07/1987SE
K863727Fixation InstrumentsHNR · Traditional 10/31/1986SE
K863725Cataract Diamond KnifeHNN · Traditional 10/31/1986SE

Questions and answers

When was Instrument Sterilization Tray cleared by the FDA?

Instrument Sterilization Tray (K863726) received a 510(k) decision of Substantially Equivalent on October 14, 1986, 21 days after the submission was received.

What is the product code of K863726?

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