RCT-1, RCT-2, RCT-3 Arthrogram Tray
FDA 510(k) K870417 · North Coast Medi-Tek
510(k) numberK870417
Submission
- Device name
- RCT-1, RCT-2, RCT-3 Arthrogram Tray
- Applicant
- North Coast Medi-Tek
Mentor, OH, US - Received
- February 3, 1987
- Decision date
- March 5, 1987
- 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 |
|---|---|---|
| K870419 | Ivr-Sp Custom Angiography TrayDQO · Traditional | 05/11/1987SE |
| K870420 | PTC-6 and PTC-8 Percutaneous CholangiographyGBZ · Traditional | 04/14/1987SESD |
| K870416 | LP Extension SetsFPK · Traditional | 04/06/1987SE |
| K870418 | MYA-1 and MYT-1 Myelogram Tray · Traditional | 03/17/1987SE |
| K854095 | Biopsy Tray I & IILRO · Traditional | 11/25/1985SESD |
Questions and answers
When was RCT-1, RCT-2, RCT-3 Arthrogram Tray cleared by the FDA?
RCT-1, RCT-2, RCT-3 Arthrogram Tray (K870417) received a 510(k) decision of Substantially Equivalent on March 5, 1987, 30 days after the submission was received.
What is the product code of K870417?
The FDA product code is FSM – Tray, Surgical, Instrument, a Class I (low risk) device regulated under 21 CFR 878.4800.