Micromedics Ear, Nose and Throat Burs
FDA 510(k) K895738 · Micromedics, Inc.
510(k) numberK895738
Submission
- Device name
- Micromedics Ear, Nose and Throat Burs
- Applicant
- Micromedics, Inc.
St. Paul, MN, US - Received
- September 26, 1989
- Decision date
- December 19, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- EQJ – Bur, Ear, Nose And Throat
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 874.4140
- Specialty
- Ear, Nose, Throat
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|---|---|---|---|
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| K041985 | XPS Curved BurEQJ · Traditional | Medtronic Xomed, Inc. | 08/12/2004SE |
| K974232 | Essential Shaver SystemEQJ · Traditional | Gyrus Ent LLC | 01/12/1998SE |
| K960853 | Ace SystemEQJ · Traditional | Xomed, Inc. | 04/03/1996SE |
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| K955294 | Sof - Abrasion BurEQJ · Traditional | Trebay Medical Corp. | 12/22/1995SE |
| K954912 | Trebay Irrigated Cutter Blade (Modification)EQJ · Traditional | Trebay Medical Corp. | 12/06/1995SE |
| K953370 | Karl Storz ENT ShaverEQJ · Traditional | KARL STORZ Endoscopy-America, Inc. | 09/06/1995SE |
| K950337 | Karl Storz Stammberger-Sachse Intranasal-FrillEQJ · Traditional | KARL STORZ Endoscopy-America, Inc. | 08/23/1995SE |
| K952609 | Redi Drill Drill SystemEQJ · Traditional | Trebay Medical Corp. | 07/31/1995SE |
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| K122526 | 360 Gas Assisted Endoscopic ApplicatorGCJ · Special | 11/16/2012SE |
| K120608 | Endoscopic ApplicatorGCJ · Traditional | 03/15/2012SE |
| K102563 | Single Cannula Extended ApplicatorKYZ · Traditional | 03/15/2011SE |
| K100754 | Graft Delivery System Model SA-6115FMF · Traditional | 06/09/2010SE |
| K073401 | Earpopper, Model EP-2000, EP-2100, EP-3000MJV · Traditional | 03/14/2008SE |
| K061092 | Baxter Duplospray Mis ApplicatorFMF · Traditional | 09/13/2006SE |
| K051157 | Instru-Safe Instrument Protection SystemsKCT · Traditional | 09/01/2005SE |
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Questions and answers
When was Micromedics Ear, Nose and Throat Burs cleared by the FDA?
Micromedics Ear, Nose and Throat Burs (K895738) received a 510(k) decision of Substantially Equivalent on December 19, 1989, 84 days after the submission was received.
What is the product code of K895738?
The FDA product code is EQJ – Bur, Ear, Nose And Throat, a Class I (low risk) device regulated under 21 CFR 874.4140.