Product code EQJ
- Device name
- Bur, Ear, Nose And Throat
- Medical specialty
- Ear, Nose, Throat
- Device class
- 1
- Regulation number
- 874.4140
- Review panel
- EN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K161514 | Precision Thin Reciprocating Blade, 0.010in. | Stryker Corporation | 2017-01-17 |
| K041985 | XPS CURVED BUR | Medtronic Xomed, Inc. | 2004-08-12 |
| K974232 | ESSENTIAL SHAVER SYSTEM | Gyrus Ent LLC | 1998-01-12 |
| K960853 | ACE SYSTEM | Xomed, Inc. | 1996-04-03 |
| K955704 | TREBAY MICRODEBRIDER SYSTEM | Trebay Medical Corp. | 1996-01-30 |
| K955294 | SOF - ABRASION BUR | Trebay Medical Corp. | 1995-12-22 |
| K954912 | TREBAY IRRIGATED CUTTER BLADE (MODIFICATION) | Trebay Medical Corp. | 1995-12-06 |
| K953370 | KARL STORZ ENT SHAVER | KARL STORZ Endoscopy-America, Inc. | 1995-09-06 |
| K950337 | KARL STORZ STAMMBERGER-SACHSE INTRANASAL-FRILL | KARL STORZ Endoscopy-America, Inc. | 1995-08-23 |
| K952609 | REDI DRILL DRILL SYSTEM | Trebay Medical Corp. | 1995-07-31 |
| K953096 | ESSENTIAL SHAVER SYSTEM | Smith & Nephew Richards, Inc. | 1995-07-28 |
| K946332 | KARL STORZ MICRO-INSTRUMENT FOR COCHLEAR IMPLANTATION | KARL STORZ Endoscopy-America, Inc. | 1995-06-05 |
| K951526 | TREBAY IRRGATED CUTTER BLADE | Trebay Medical Corp. | 1995-05-12 |
| K935584 | MEDNEXT BUR | Mednext, Inc. | 1994-02-22 |
| K895738 | MICROMEDICS EAR, NOSE AND THROAT BURS | Micromedics, Inc. | 1989-12-19 |
| K893499 | CMS FAST CUT, CMS DIAMOND AND CMS WIRE PASS | Cmsi | 1989-11-16 |
| K802503 | MICRO-SUGICAL POWER INSTRUMENT SYSTEM | Spire Medical, Inc. | 1980-10-31 |
| K792028 | OTOTOME BUR | American Sterilizer Co. | 1979-10-26 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613327576801 | PELLO | STRYKER CORPORATION | 2024-11-13 |
| 07613327576825 | PELLO | STRYKER CORPORATION | 2024-11-13 |
| 07630055502490 | Bur PM2-70 50K Carb Ø6.0 | Bien-Air Surgery SA | 2020-05-28 |
| 07630055502483 | Bur PM2-70 50K Carb Ø5.0 | Bien-Air Surgery SA | 2020-05-28 |
| 07630055502476 | Bur PM2-70 50K Carb Ø4.5 | Bien-Air Surgery SA | 2020-05-28 |
| 07630055502469 | Bur PM2-70 50K Carb Ø4.0 | Bien-Air Surgery SA | 2020-05-28 |
| 07630055502452 | Bur PM2-70 50K Carb Ø3.5 | Bien-Air Surgery SA | 2020-05-28 |
| 07630055502445 | Bur PM2-70 50K Carb Ø3.1 | Bien-Air Surgery SA | 2020-05-28 |
| 07630055502438 | Bur PM2-70 50K Carb Ø2.7 | Bien-Air Surgery SA | 2020-05-28 |
| 07630055502421 | Bur PM2-70 50K Carb Ø2.3 | Bien-Air Surgery SA | 2020-05-28 |
| 07630055502414 | Bur PM2-70 50K Carb Ø1.8 | Bien-Air Surgery SA | 2020-05-28 |
| 07630055502407 | Bur PM2-70 50K Carb Ø1.4 | Bien-Air Surgery SA | 2020-05-28 |
| 07630055502391 | Bur PM2-70 50K Carb Ø1.0 | Bien-Air Surgery SA | 2020-05-28 |
| 07630055502384 | Bur PM2-70 50K Carb Ø0.8 | Bien-Air Surgery SA | 2020-05-28 |
| 07630055502377 | Bur PM2-70 50K Carb Ø0.5 | Bien-Air Surgery SA | 2020-05-28 |
| 07630055502360 | Bur PM2-70 50K Diam Ø7.0 | Bien-Air Surgery SA | 2020-05-28 |
| 07630055502353 | Bur PM2-70 50K Diam Ø6.0 | Bien-Air Surgery SA | 2020-05-28 |
| 07630055502346 | Bur PM2-70 50K Diam Ø5.0 | Bien-Air Surgery SA | 2020-05-28 |
| 07630055502339 | Bur PM2-70 50K Diam Ø4.5 | Bien-Air Surgery SA | 2020-05-28 |
| 07630055502322 | Bur PM2-70 50K Diam Ø4.0 | Bien-Air Surgery SA | 2020-05-28 |
| 07630055502315 | Bur PM2-70 50K Diam Ø3.5 | Bien-Air Surgery SA | 2020-05-28 |
| 07630055502308 | Bur PM2-70 50K Diam Ø3.1 | Bien-Air Surgery SA | 2020-05-28 |
| 07630055502292 | Bur PM2-70 50K Diam Ø2.7 | Bien-Air Surgery SA | 2020-05-28 |
| 07630055502285 | Bur PM2-70 50K Diam Ø2.3 | Bien-Air Surgery SA | 2020-05-28 |
| 07630055502278 | Bur PM2-70 50K Diam Ø1.8 | Bien-Air Surgery SA | 2020-05-28 |
| 07630055502261 | Bur PM2-70 50K Diam Ø1.4 | Bien-Air Surgery SA | 2020-05-28 |
| 07630055502254 | Bur PM2-70 50K Diam Ø1.0 | Bien-Air Surgery SA | 2020-05-28 |
| 07630055502247 | Bur PM2-70 50K Diam Ø0.8 | Bien-Air Surgery SA | 2020-05-28 |
| 07630055502230 | Bur PM2-70 50K Diam Ø0.6 | Bien-Air Surgery SA | 2020-05-28 |
| 07613153064794 | NA | STRYKER CORPORATION | 2016-09-23 |