Instrument Tray Liner
FDA 510(k) K971217 · General Hospital Supply Corp.
510(k) numberK971217
Submission
- Device name
- Instrument Tray Liner
- Applicant
- General Hospital Supply Corp.
Wilton, CT, US - Received
- April 2, 1997
- Decision date
- May 6, 1997
- 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 |
|---|---|---|---|
| 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 |
| K905682 | Richard-Allan Clamp CoversFSM · Traditional | Richard-Allan Medical | 02/19/1991SE |
Questions and answers
When was Instrument Tray Liner cleared by the FDA?
Instrument Tray Liner (K971217) received a 510(k) decision of Substantially Equivalent on May 6, 1997, 34 days after the submission was received.
What is the product code of K971217?
The FDA product code is FSM – Tray, Surgical, Instrument, a Class I (low risk) device regulated under 21 CFR 878.4800.