Scanlan (TM) Instrument Tray
FDA 510(k) K864920 · Scanlan Intl., Inc.
510(k) numberK864920
Submission
- Device name
- Scanlan (TM) Instrument Tray
- Applicant
- Scanlan Intl., Inc.
Saint Paul, MN, US - Received
- December 16, 1986
- Decision date
- January 12, 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 |
|---|---|---|
| K960372 | Scanlan Heifetz Aneurysm Elgiloy Clip SystemHCH · Traditional | 04/26/1996SE |
| K945474 | Scanlan(R) Thoracoscopic Scissors, Clamp, Forceps, Needle HolderGCJ · Traditional | 12/05/1994SE |
| K911184 | Scanlan/Taheri ValvulotomeMGZ · Traditional | 02/18/1992SE |
| K864919 | Scanlan (TM) Vein/Graft HolderKPK · Traditional | 01/12/1987SE |
| K851825 | Scanlan Tunneler, Sheath & TipDWS · Traditional | 07/12/1985SE |
| K841521 | Scanlan EndarsectorDWX · Traditional | 08/03/1984SE |
| K841513 | Scanlan Atraum Instrument Jaw Cover · Traditional | 07/06/1984SE |
| K841085 | Scanlan Colormark Skin MarkerFZZ · Traditional | 06/11/1984SE |
| K841515 | Scanlan Vascu-Statt IIHRG · Traditional | 06/05/1984SE |
| K841514 | Scanlan Vascu-Statt II ApproximatorHRQ · Traditional | 06/05/1984SE |
Questions and answers
When was Scanlan (TM) Instrument Tray cleared by the FDA?
Scanlan (TM) Instrument Tray (K864920) received a 510(k) decision of Substantially Equivalent on January 12, 1987, 27 days after the submission was received.
What is the product code of K864920?
The FDA product code is FSM – Tray, Surgical, Instrument, a Class I (low risk) device regulated under 21 CFR 878.4800.