Arthrogram Tray
FDA 510(k) K950683 · Surgical Technologies, Inc.
510(k) numberK950683
Submission
- Device name
- Arthrogram Tray
- Applicant
- Surgical Technologies, Inc.
Salt Lake City, UT, US - Received
- February 14, 1995
- Decision date
- May 6, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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More from Omega Medical Imaging, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K941992 | CystoscopeFBO · Traditional | 11/30/1995SE |
| K942029 | ArthroscopeHRX · Traditional | 11/08/1995SE |
| K946136 | Infinitech Lighted Infusion CannulaMPA · Traditional | 10/02/1995SE |
| K952566 | OscilflatorMAV · Traditional | 08/31/1995SE |
| K951918 | Surgical Technologies, Inc. SyringeFMF · Traditional | 07/20/1995SE |
| K946135 | Infinitech Aspirating Laser ProbeHQE · Traditional | 04/18/1995SE |
| K946181 | Infinitech Soft Tip Flute NeedleHQE · Traditional | 03/14/1995SE |
| K942030 | Biopsy ScissorsOCZ · Traditional | 06/27/1994SE |
| K942482 | Pressure Monitoring ExtensionDQO · Traditional | 06/14/1994SE |
| K941161 | Flexible Grasping ForcepsEOQ · Traditional | 05/04/1994SE |
Questions and answers
When was Arthrogram Tray cleared by the FDA?
Arthrogram Tray (K950683) received a 510(k) decision of Substantially Equivalent on May 6, 1995, 81 days after the submission was received.
What is the product code of K950683?
The FDA product code is JAA – System, X-Ray, Fluoroscopic, Image-Intensified, a Class II (moderate risk) device regulated under 21 CFR 892.1650.