Open Heart Tray

FDA 510(k) K912053 · Medical Device Inspection Co., Inc.

Substantially Equivalent

510(k) numberK912053

Submission

Device name
Open Heart Tray
Applicant
Medical Device Inspection Co., Inc.
Great Neck, NY, US
Received
May 9, 1991
Decision date
August 26, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

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
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
K905682Richard-Allan Clamp CoversFSM · Traditional Richard-Allan Medical02/19/1991SE

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K931594Thera-Turn CM-1000 Mattress Overlay SystemIOQ · Traditional 12/21/1993SE
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K933578Powermatic Mat PlatformINQ · Traditional 11/05/1993SE
K933577Powermatic Examination TableINQ · Traditional 09/30/1993SE
K922045Shower ChairsINM · Traditional 05/26/1992SE
K912075C-Section TrayKNA · Traditional 04/07/1992SESK
K914174Sterile Disposable Wet Skin Scrub TrayLRO · Traditional 02/24/1992SEKD

Questions and answers

When was Open Heart Tray cleared by the FDA?

Open Heart Tray (K912053) received a 510(k) decision of Substantially Equivalent on August 26, 1991, 109 days after the submission was received.

What is the product code of K912053?

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