Operating Room Tray Set
FDA 510(k) K840021 · Medi-Plast Intl., Inc.
510(k) numberK840021
Submission
- Device name
- Operating Room Tray Set
- Applicant
- Medi-Plast Intl., Inc.
Mchenry, IL, US - Received
- January 5, 1984
- Decision date
- March 15, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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) | Device | Applicant | Decision |
|---|---|---|---|
| K971217 | Instrument Tray LinerFSM · Traditional | General Hospital Supply Corp. | 05/06/1997SE |
| K962328 | Single Use Instrument TrayFSM · Traditional | Medcare Medical Group, Inc. | 08/09/1996SE |
| K944025 | Surgical Instrument TrayFSM · Traditional | Riley Medical, Inc. | 11/22/1994SE |
| K912106 | Arthroscopy TrayFSM · Traditional | Medical Device Inspection Co., Inc. | 08/29/1991SE |
| K912053 | Open Heart TrayFSM · Traditional | Medical Device Inspection Co., Inc. | 08/26/1991SE |
| K912052 | Heart Cath TrayFSM · Traditional | Medical Device Inspection Co., Inc. | 08/20/1991SE |
| K912104 | Major Basin TrayFSM · Traditional | Medical Device Inspection Co., Inc. | 08/09/1991SE |
| K910570 | Splinter TweezersFSM · Traditional | Solan Scissors Sales | 05/31/1991SE |
| K911601 | Reddick Trocar and CannulaFSM · Traditional | Ideal Medical, Inc. | 05/21/1991SE |
| K910328 | Key Comfort GripsFSM · Traditional | Key Surgical, Inc. | 03/06/1991SE |
More from Key Surgical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K954284 | Medi-Plast 2 Port Manifold (Right on)DTL · Traditional | 02/12/1996SE |
| K873588 | 10CC Control SyringeFMF · Traditional | 10/23/1987SE |
| K863402 | Medi-Plast Disposable ManifoldDTL · Traditional | 10/22/1986SE |
| K861785 | Fluoroscope Band BagJAA · Traditional | 06/13/1986SE |
| K851489 | Arterial-Venous Compression Dressing · Traditional | 06/11/1985SE |
| K842136 | Sterile Pan SetFRG · Traditional | 07/06/1984SE |
| K840022 | Heart Catheterization Tray SetDRE · Traditional | 02/04/1984SE |
| K811268 | Bottle-To-BottleKPE · Traditional | 06/18/1981SE |
| K811234 | I.V. Bottle (Ridgid)KPE · Traditional | 06/18/1981SE |
| K811233 | I.V. Plastic BagKPE · Traditional | 06/17/1981SE |
Questions and answers
When was Operating Room Tray Set cleared by the FDA?
Operating Room Tray Set (K840021) received a 510(k) decision of Substantially Equivalent on March 15, 1984, 70 days after the submission was received.
What is the product code of K840021?
The FDA product code is FSM – Tray, Surgical, Instrument, a Class I (low risk) device regulated under 21 CFR 878.4800.