Mednext 1000 Drill
FDA 510(k) K972308 · Mednext, Inc.
510(k) numberK972308
Submission
- Device name
- Mednext 1000 Drill
- Applicant
- Mednext, Inc.
West Palm Beach, FL, US - Received
- June 20, 1997
- Decision date
- August 20, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
| K962789 | Surgical Kit-Acufex Mosaicplasty SystemGEY · Traditional | Smith & Nephew Endoscopy, Inc. | 08/14/1996SE |
More from Smith & Nephew Endoscopy, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K983092 | Triton Hudson Chuck AttachmentHBB · Traditional | 11/06/1998SE |
| K970023 | Mednext Surgical BurHWE · Traditional | 02/28/1997SE |
| K943108 | Mednext Micro-DrillERL · Traditional | 08/17/1994SE |
| K935861 | Mednext BurHBE · Traditional | 05/03/1994SE |
| K935584 | Mednext BurEQJ · Traditional | 02/22/1994SE |
| K926547 | Mednext 1000 Bone Dissecting SystemHSZ · Traditional | 07/22/1993SE |
Questions and answers
When was Mednext 1000 Drill cleared by the FDA?
Mednext 1000 Drill (K972308) received a 510(k) decision of Substantially Equivalent on August 20, 1997, 61 days after the submission was received.
What is the product code of K972308?
The FDA product code is GEY – Motor, Surgical Instrument, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 878.4820.