Single Use Instrument Tray
FDA 510(k) K962328 · Medcare Medical Group, Inc.
510(k) numberK962328
Submission
- Device name
- Single Use Instrument Tray
- Applicant
- Medcare Medical Group, Inc.
East Swanzey, NH, US - Received
- June 6, 1996
- Decision date
- August 9, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
| K905682 | Richard-Allan Clamp CoversFSM · Traditional | Richard-Allan Medical | 02/19/1991SE |
More from Richard-Allan Medical
| 510(k) | Device | Decision |
|---|---|---|
| K973497 | HuberlocLJT · Traditional | 01/13/1998SE |
| K970152 | Biopsy TrayFRG · Traditional | 03/05/1997SN |
| K962849 | Catheter Insertion TrayLJS · Traditional | 10/07/1996SE |
| K961075 | Medcare Regional Anethesia KitCAZ · Traditional | 09/06/1996SEKD |
| K962527 | General Purpose Dental TrayEIA · Traditional | 08/01/1996SE |
| K961880 | Medcare Suction Connecting TubingGCX · Traditional | 07/19/1996SE |
| K961167 | Medcare Tracheostomy Care TrayLRQ · Traditional | 07/02/1996SESK |
Questions and answers
When was Single Use Instrument Tray cleared by the FDA?
Single Use Instrument Tray (K962328) received a 510(k) decision of Substantially Equivalent on August 9, 1996, 64 days after the submission was received.
What is the product code of K962328?
The FDA product code is FSM – Tray, Surgical, Instrument, a Class I (low risk) device regulated under 21 CFR 878.4800.