Arthroscopy Tray
FDA 510(k) K912106 · Medical Device Inspection Co., Inc.
510(k) numberK912106
Submission
- Device name
- Arthroscopy Tray
- Applicant
- Medical Device Inspection Co., Inc.
Great Neck, NY, US - Received
- May 13, 1991
- Decision date
- August 29, 1991
- 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 |
| K962328 | Single Use Instrument TrayFSM · Traditional | Medcare Medical Group, Inc. | 08/09/1996SE |
| K944025 | Surgical Instrument TrayFSM · Traditional | Riley Medical, Inc. | 11/22/1994SE |
| 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 |
|---|---|---|
| K945826 | J & J I-330 Series Physiological Monitoring & Biofeedback Instument and Use Software…HCC · Traditional | 08/04/1995SE |
| K932072 | Jarit Surgical InstrumentsHET · Traditional | 01/11/1994SE |
| K931594 | Thera-Turn CM-1000 Mattress Overlay SystemIOQ · Traditional | 12/21/1993SE |
| K933581 | Powermatic Treatment TableINQ · Traditional | 11/05/1993SE |
| K933580 | Power Work TableINQ · Traditional | 11/05/1993SE |
| K933578 | Powermatic Mat PlatformINQ · Traditional | 11/05/1993SE |
| K933577 | Powermatic Examination TableINQ · Traditional | 09/30/1993SE |
| K922045 | Shower ChairsINM · Traditional | 05/26/1992SE |
| K912075 | C-Section TrayKNA · Traditional | 04/07/1992SESK |
| K914174 | Sterile Disposable Wet Skin Scrub TrayLRO · Traditional | 02/24/1992SEKD |
Questions and answers
When was Arthroscopy Tray cleared by the FDA?
Arthroscopy Tray (K912106) received a 510(k) decision of Substantially Equivalent on August 29, 1991, 108 days after the submission was received.
What is the product code of K912106?
The FDA product code is FSM – Tray, Surgical, Instrument, a Class I (low risk) device regulated under 21 CFR 878.4800.