Various Instruments & Instrument Trays
FDA 510(k) K830219 · Ascep, Inc.
510(k) numberK830219
Submission
- Device name
- Various Instruments & Instrument Trays
- Applicant
- Ascep, Inc.
Mchenry, IL, US - Received
- January 24, 1983
- Decision date
- April 12, 1983
- 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 |
|---|---|---|
| K822893 | G.E.V. Disposable ScalpelsGDX · Traditional | 10/22/1982SE |
| K810004 | Sterile Disposable Instrument TraysFSM · Traditional | 01/26/1981SE |
| K802726 | Instruments Nonsterile & SterileHAO · Traditional | 11/19/1980SE |
| K791886 | I.V. Care KitKGX · Traditional | 10/26/1979SE |
| K791885 | I.V. Start SetKGX · Traditional | 10/22/1979SE |
| K791889 | Suture Removal Tray, Reorder 7950&7951FSM · Traditional | 10/17/1979SE |
| K791888 | Catheter Care Kit Reorder 7940&7941EFQ · Traditional | 10/17/1979SE |
| K791887 | Central Venous Catheter Dressing TrayFSM · Traditional | 10/17/1979SE |
Questions and answers
When was Various Instruments & Instrument Trays cleared by the FDA?
Various Instruments & Instrument Trays (K830219) received a 510(k) decision of Substantially Equivalent on April 12, 1983, 78 days after the submission was received.
What is the product code of K830219?
The FDA product code is FSM – Tray, Surgical, Instrument, a Class I (low risk) device regulated under 21 CFR 878.4800.