Ototome Bur
FDA 510(k) K792028 · American Sterilizer Co.
510(k) numberK792028
Submission
- Device name
- Ototome Bur
- Applicant
- American Sterilizer Co.
Mchenry, IL, US - Received
- October 9, 1979
- Decision date
- October 26, 1979
- 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
Other 510(k)s with product code EQJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K161514 | Precision Thin Reciprocating Blade, 0.010in.EQJ · Traditional | Stryker Corporation | 01/17/2017SE |
| 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 |
| K955704 | Trebay Microdebrider SystemEQJ · Traditional | Trebay Medical Corp. | 01/30/1996SE |
| 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 |
More from Trebay Medical Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K943288 | Amsco SQ240 Surgical LightFSY · Traditional | 10/17/1994SE |
| K931872 | The Eagle 3017 100% Ethylene Oxide SterilizerFLF · Traditional | 02/07/1994SE |
| K922485 | Chemdi-Vhp Chemical IndicatorJOJ · Traditional | 09/29/1993SE |
| K930493 | Quantum 3080 Surgical TableFQO · Traditional | 06/22/1993SE |
| K905816 | Orthovision TableJEB · Traditional | 03/06/1991SE |
| K896674 | Amsco Quantum LightFSY · Traditional | 01/03/1990SE |
| K895164 | Eagle DSECG · Traditional | 11/17/1989SE |
| K882660 | General Surgical Table and AccessoriesFQO · Traditional | 07/25/1988SE |
| K880198 | Gemini Surgical LightFSS · Traditional | 02/10/1988SE |
| K864846 | Radiographic - Leg SectionKQS · Traditional | 12/24/1986SE |
Questions and answers
When was Ototome Bur cleared by the FDA?
Ototome Bur (K792028) received a 510(k) decision of Substantially Equivalent on October 26, 1979, 17 days after the submission was received.
What is the product code of K792028?
The FDA product code is EQJ – Bur, Ear, Nose And Throat, a Class I (low risk) device regulated under 21 CFR 874.4140.