Vistek Electronic Controller
FDA 510(k) K904682 · Vistek Corp.
510(k) numberK904682
Submission
- Device name
- Vistek Electronic Controller
- Applicant
- Vistek Corp.
Goleta, CA, US - Received
- October 15, 1990
- Decision date
- December 18, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GEY – Motor, Surgical Instrument, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4820
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GEY
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|---|---|---|---|
| K050519 | Advanced Turbo Drive SystemGEY · Special | Linvatec Corp. | 05/17/2005SE |
| K020621 | Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; WandsGEY · Special | Arthrocare Corp. | 03/28/2002SE |
| K012738 | Symphony Graft Delivery System (GDS)GEY · Traditional | Depuyacromed | 11/14/2001SE |
| K972308 | Mednext 1000 DrillGEY · Traditional | Mednext, Inc. | 08/20/1997SE |
| K971941 | Aqua SprayGEY · Traditional | Boyd Industries, Inc. | 08/14/1997SE |
| K971782 | Bone and Marrow Collection System KitGEY · Traditional | Biomedical Ent., Inc. | 07/29/1997SE |
| K971268 | Bone & Marrow Cllection SystemGEY · Traditional | Biomedical International Corp. | 07/03/1997SE |
| K964252 | OrthochuckGEY · Traditional | Buckman Co., Inc. | 05/27/1997SE |
| K970530 | Anspach Lubricating System IIGEY · Traditional | The Anspach Effort, Inc. | 05/05/1997SE |
| K964073 | Bme Bone Drill BitsGEY · Traditional | Biomedical Ent., Inc. | 11/14/1996SE |
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Questions and answers
When was Vistek Electronic Controller cleared by the FDA?
Vistek Electronic Controller (K904682) received a 510(k) decision of Substantially Equivalent on December 18, 1990, 64 days after the submission was received.
What is the product code of K904682?
The FDA product code is GEY – Motor, Surgical Instrument, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 878.4820.