EQJ · Bur, Ear, Nose And Throat
Ear, Nose, Throat · 21 CFR 874.4140 · Class 1
Overview
| Product Code | EQJ |
|---|---|
| Device Name | Bur, Ear, Nose And Throat |
| Regulation | 21 CFR 874.4140 |
| Device Class | Class 1 |
| Review Panel | Ear, Nose, Throat |
Identification
An ear, nose, and throat bur is a device consisting of an interchangeable drill bit that is intended for use in an ear, nose, and throat electric or pneumatic surgical drill (§ 874.4250) for incising or removing bone in the ear, nose, or throat area. The bur consists of a carbide cutting tip on a metal shank or a coating of diamond on a metal shank. The device is used in mastoid surgery, frontal sinus surgery, and surgery of the facial nerves.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.
Cleared Devices (18)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K161514 | Precision Thin Reciprocating Blade, 0.010in. | Stryker Corporation | Jan 17, 2017 | SESE |
| K041985 | XPS CURVED BUR | Medtronic Xomed, Inc. | Aug 12, 2004 | SESE |
| K974232 | ESSENTIAL SHAVER SYSTEM | Gyrus Ent LLC | Jan 12, 1998 | SESE |
| K960853 | ACE SYSTEM | Xomed, Inc. | Apr 3, 1996 | SESE |
| K955704 | TREBAY MICRODEBRIDER SYSTEM | Trebay Medical Corp. | Jan 30, 1996 | SESE |
| K955294 | SOF - ABRASION BUR | Trebay Medical Corp. | Dec 22, 1995 | SESE |
| K954912 | TREBAY IRRIGATED CUTTER BLADE (MODIFICATION) | Trebay Medical Corp. | Dec 6, 1995 | SESE |
| K953370 | KARL STORZ ENT SHAVER | KARL STORZ Endoscopy-America, Inc. | Sep 6, 1995 | SESE |
| K950337 | KARL STORZ STAMMBERGER-SACHSE INTRANASAL-FRILL | KARL STORZ Endoscopy-America, Inc. | Aug 23, 1995 | SESE |
| K952609 | REDI DRILL DRILL SYSTEM | Trebay Medical Corp. | Jul 31, 1995 | SESE |
| K953096 | ESSENTIAL SHAVER SYSTEM | Smith & Nephew Richards, Inc. | Jul 28, 1995 | SESE |
| K946332 | KARL STORZ MICRO-INSTRUMENT FOR COCHLEAR IMPLANTATION | KARL STORZ Endoscopy-America, Inc. | Jun 5, 1995 | SESE |
| K951526 | TREBAY IRRGATED CUTTER BLADE | Trebay Medical Corp. | May 12, 1995 | SESE |
| K935584 | MEDNEXT BUR | Mednext, Inc. | Feb 22, 1994 | SESE |
| K895738 | MICROMEDICS EAR, NOSE AND THROAT BURS | Micromedics, Inc. | Dec 19, 1989 | SESE |
| K893499 | CMS FAST CUT, CMS DIAMOND AND CMS WIRE PASS | Cmsi | Nov 16, 1989 | SESE |
| K802503 | MICRO-SUGICAL POWER INSTRUMENT SYSTEM | Spire Medical, Inc. | Oct 31, 1980 | SESE |
| K792028 | OTOTOME BUR | American Sterilizer Co. | Oct 26, 1979 | SESE |
Top Applicants
- Trebay Medical Corp. — 5 clearances
- KARL STORZ Endoscopy-America, Inc. — 3 clearances
- Xomed, Inc. — 1 clearance
- Stryker Corporation — 1 clearance
- Spire Medical, Inc. — 1 clearance
