Bur, Ear, Nose And Throat
The ear, nose, and throat surgical bur is a rotary cutting instrument used to remove or reshape bone and tissue in ENT surgical procedures such as mastoidectomy or sinus surgery. It is classified as FDA Class 1, indicating minimal risk and requiring only general controls. The product code is EQJ, regulated under 21 CFR 874.4140 in the Ear, Nose, Throat specialty. No implant, life-sustaining, GMP-exempt, or third-party review designations apply.
Basic Information
- Product Code
- EQJ
- Device Class
- FDA class 1
- Regulation Number
- 874.4140
- Medical Specialty
- Ear, Nose, Throat
- Review Panel
- EN
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 18 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K161514 | Precision Thin Reciprocating Blade, 0.010in. | Jan 17, 2017 | Substantially Equivalent | STRYKER CORPORATION |
| K041985 | XPS CURVED BUR | Aug 12, 2004 | Substantially Equivalent | MEDTRONIC XOMED, INC. |
| K974232 | ESSENTIAL SHAVER SYSTEM | Jan 12, 1998 | Substantially Equivalent | GYRUS ENT L.L.C. |
| K960853 | ACE SYSTEM | Apr 03, 1996 | Substantially Equivalent | XOMED, INC. |
| K955704 | TREBAY MICRODEBRIDER SYSTEM | Jan 30, 1996 | Substantially Equivalent | TREBAY MEDICAL CORP. |
| K955294 | SOF - ABRASION BUR | Dec 22, 1995 | Substantially Equivalent | TREBAY MEDICAL CORP. |
| K954912 | TREBAY IRRIGATED CUTTER BLADE (MODIFICATION) | Dec 06, 1995 | Substantially Equivalent | TREBAY MEDICAL CORP. |
| K953370 | KARL STORZ ENT SHAVER | Sep 06, 1995 | Substantially Equivalent | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| K950337 | KARL STORZ STAMMBERGER-SACHSE INTRANASAL-FRILL | Aug 23, 1995 | Substantially Equivalent | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| K952609 | REDI DRILL DRILL SYSTEM | Jul 31, 1995 | Substantially Equivalent | TREBAY MEDICAL CORP. |
| K953096 | ESSENTIAL SHAVER SYSTEM | Jul 28, 1995 | Substantially Equivalent | SMITH & NEPHEW RICHARDS, INC. |
| K946332 | KARL STORZ MICRO-INSTRUMENT FOR COCHLEAR IMPLANTATION | Jun 05, 1995 | Substantially Equivalent | KARL STORZ ENDOSCOPY-AMERICA, INC. |
| K951526 | TREBAY IRRGATED CUTTER BLADE | May 12, 1995 | Substantially Equivalent | TREBAY MEDICAL CORP. |
| K935584 | MEDNEXT BUR | Feb 22, 1994 | Substantially Equivalent | MEDNEXT, INC. |
| K895738 | MICROMEDICS EAR, NOSE AND THROAT BURS | Dec 19, 1989 | Substantially Equivalent | MICROMEDICS, INC. |
| K893499 | CMS FAST CUT, CMS DIAMOND AND CMS WIRE PASS | Nov 16, 1989 | Substantially Equivalent | CMSI |
| K802503 | MICRO-SUGICAL POWER INSTRUMENT SYSTEM | Oct 31, 1980 | Substantially Equivalent | SPIRE MEDICAL, INC. |
| K792028 | OTOTOME BUR | Oct 26, 1979 | Substantially Equivalent | AMERICAN STERILIZER CO. |
FEI Numbers
This FDA classification entry is associated with 88 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 88 registration numbers. Click on an entry to view related FDA registrations.