EQJ — Bur, Ear, Nose And Throat Class I
FDA product code EQJ covers "Bur, Ear, Nose And Throat", a Class I medical device regulated under 21 CFR 874.4140. Submissions are reviewed by the Ear, Nose, Throat panel. At least 18 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- EQJ
- Device Class
- Class I
- Regulation Number
- 874.4140
- Submission Type
- Review Panel
- EN
- Medical Specialty
- Ear, Nose, Throat
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K161514 | stryker corporation | Precision Thin Reciprocating Blade, 0.010in. | January 17, 2017 |
| K041985 | medtronic xomed | XPS CURVED BUR | August 12, 2004 |
| K974232 | gyrus ent | ESSENTIAL SHAVER SYSTEM | January 12, 1998 |
| K960853 | xomed | ACE SYSTEM | April 3, 1996 |
| K955704 | trebay medical | TREBAY MICRODEBRIDER SYSTEM | January 30, 1996 |
| K955294 | trebay medical | SOF - ABRASION BUR | December 22, 1995 |
| K954912 | trebay medical | TREBAY IRRIGATED CUTTER BLADE (MODIFICATION) | December 6, 1995 |
| K953370 | karl storz endoscopy-america | KARL STORZ ENT SHAVER | September 6, 1995 |
| K950337 | karl storz endoscopy-america | KARL STORZ STAMMBERGER-SACHSE INTRANASAL-FRILL | August 23, 1995 |
| K952609 | trebay medical | REDI DRILL DRILL SYSTEM | July 31, 1995 |
| K953096 | smith and nephew richards | ESSENTIAL SHAVER SYSTEM | July 28, 1995 |
| K946332 | karl storz endoscopy-america | KARL STORZ MICRO-INSTRUMENT FOR COCHLEAR IMPLANTATION | June 5, 1995 |
| K951526 | trebay medical | TREBAY IRRGATED CUTTER BLADE | May 12, 1995 |
| K935584 | mednext | MEDNEXT BUR | February 22, 1994 |
| K895738 | micromedics | MICROMEDICS EAR, NOSE AND THROAT BURS | December 19, 1989 |
| K893499 | cmsi | CMS FAST CUT, CMS DIAMOND AND CMS WIRE PASS | November 16, 1989 |
| K802503 | spire medical | MICRO-SUGICAL POWER INSTRUMENT SYSTEM | October 31, 1980 |
| K792028 | american sterilizer | OTOTOME BUR | October 26, 1979 |