Edi-Bur Microdrill Systems
FDA 510(k) K945438 · Micromed Development Corp.
510(k) numberK945438
Submission
- Device name
- Edi-Bur Microdrill Systems
- Applicant
- Micromed Development Corp.
Clearwater, FL, US - Received
- October 20, 1994
- Decision date
- November 22, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| K171840 | Stryker Consolidated Operating Room Equipment (CORE) 2 ConsoleERL · Traditional | Stryker Corporation | 09/15/2017SE |
More from Stryker Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K945105 | Poly/Platinum Wire PistonETB · Traditional | 05/14/1996SE |
| K945831 | Disposable Joint Aspiration/Injection Diagnostic KitLRO · Traditional | 01/20/1995SE |
| K945242 | Nerve Monitor Electrodes/Stimulator ProbesETN · Traditional | 12/27/1994SE |
| K945108 | Poly PistonETB · Traditional | 11/22/1994SE |
| K945107 | Poly-Wire PistonETB · Traditional | 11/22/1994SE |
| K945106 | Micromed Total Regular and Partial OffsetETA · Traditional | 11/22/1994SE |
| K945104 | Micromed Partial Regular and Partial OffsetETB · Traditional | 11/22/1994SE |
| K943848 | Collar Button Venturi Vent TubeETD · Traditional | 09/16/1994SE |
| K943849 | Gromment Style Venturi TubeETD · Traditional | 09/02/1994SE |
| K943847 | Bobbin Style Venturi Vent TubeETD · Traditional | 09/02/1994SE |
Questions and answers
When was Edi-Bur Microdrill Systems cleared by the FDA?
Edi-Bur Microdrill Systems (K945438) received a 510(k) decision of Substantially Equivalent on November 22, 1994, 33 days after the submission was received.
What is the product code of K945438?
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.