Mednext Micro-Drill
FDA 510(k) K943108 · Mednext, Inc.
510(k) numberK943108
Submission
- Device name
- Mednext Micro-Drill
- Applicant
- Mednext, Inc.
Riviera Beach, FL, US - Received
- June 29, 1994
- Decision date
- August 17, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- ERL – Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4250
- Specialty
- Ear, Nose, Throat
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| K233958 | hekaDrillERL · Traditional | Zethon, Ltd. | 03/14/2024SE |
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| K180063 | OCM-G1 AttachmentERL · Special | The Anspach Effort, Inc. | 03/27/2018SE |
| K171840 | Stryker Consolidated Operating Room Equipment (CORE) 2 ConsoleERL · Traditional | Stryker Corporation | 09/15/2017SE |
More from Stryker Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K983092 | Triton Hudson Chuck AttachmentHBB · Traditional | 11/06/1998SE |
| K972308 | Mednext 1000 DrillGEY · Traditional | 08/20/1997SE |
| K970023 | Mednext Surgical BurHWE · Traditional | 02/28/1997SE |
| 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 Micro-Drill cleared by the FDA?
Mednext Micro-Drill (K943108) received a 510(k) decision of Substantially Equivalent on August 17, 1994, 49 days after the submission was received.
What is the product code of K943108?
The FDA product code is ERL – Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece, a Class II (moderate risk) device regulated under 21 CFR 874.4250.