Sterile Instrument Trays-Various
FDA 510(k) K843723 · E.M. Adams
510(k) numberK843723
Submission
- Device name
- Sterile Instrument Trays-Various
- Applicant
- E.M. Adams
Medfield, MA, US - Received
- September 24, 1984
- Decision date
- October 23, 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 |
|---|---|---|
| K971948 | Patient RestraintFMQ · Traditional | 08/06/1997SE |
| K971536 | Restraints (Vests and Jackets)FMQ · Traditional | 07/01/1997SE |
| K905173 | Splash GuardKYZ · Traditional | 04/25/1991SE |
| K910468 | Sterile Disposable Drape(S)FZI · Traditional | 03/21/1991SE |
| K873978 | Disposable Bipolar ForcepsGEN · Traditional | 11/23/1987SE |
| K850063 | Instrument Pocket · Traditional | 02/21/1985SE |
| K843724 | I.V. Start Kit & Obstetrical KitKKX · Traditional | 01/10/1985SE |
| K843783 | Wet PackEFQ · Traditional | 12/19/1984SE |
| K843782 | Dry TrayEFQ · Traditional | 12/13/1984SE |
| K843115 | Sterile Solution BowlKDD · Traditional | 09/07/1984SE |
Questions and answers
When was Sterile Instrument Trays-Various cleared by the FDA?
Sterile Instrument Trays-Various (K843723) received a 510(k) decision of Substantially Equivalent on October 23, 1984, 29 days after the submission was received.
What is the product code of K843723?
The FDA product code is FSM – Tray, Surgical, Instrument, a Class I (low risk) device regulated under 21 CFR 878.4800.