Product code EQJ— Ear, Nose, Throat
ESSENTIAL SHAVER SYSTEM
- Classification name
- Bur, Ear, Nose And Throat
- Device class
- Class 1
- Regulation
- 21 CFR 874.4140
- Advisory panel
- Ear, Nose, Throat
- Total cleared
- 18
- First cleared
- Most recent
Market context for product code EQJ
FDA has cleared devices under product code EQJ between 1979 and 2017, filed by 12 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 2017
- 2004
- 1998
- 1996
- 1995
- 1994
- 1989
- 1980
- 1979
Top applicants under product code EQJ
Adverse events under product code EQJ
product code EQJ- Malfunction
- 1,552
- Total
- 1,552
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code EQJ
- K161514 — Precision Thin Reciprocating Blade, 0.010in.
- K041985 — XPS CURVED BUR
- K974232 — ESSENTIAL SHAVER SYSTEM
- K960853 — ACE SYSTEM
- K955704 — TREBAY MICRODEBRIDER SYSTEM
- K955294 — SOF - ABRASION BUR
- K954912 — TREBAY IRRIGATED CUTTER BLADE (MODIFICATION)
- K953370 — KARL STORZ ENT SHAVER
- K950337 — KARL STORZ STAMMBERGER-SACHSE INTRANASAL-FRILL
- K952609 — REDI DRILL DRILL SYSTEM
- K953096 — ESSENTIAL SHAVER SYSTEM
- K946332 — KARL STORZ MICRO-INSTRUMENT FOR COCHLEAR IMPLANTATION
- K951526 — TREBAY IRRGATED CUTTER BLADE
- K935584 — MEDNEXT BUR
- K895738 — MICROMEDICS EAR, NOSE AND THROAT BURS
- K893499 — CMS FAST CUT, CMS DIAMOND AND CMS WIRE PASS
- K802503 — MICRO-SUGICAL POWER INSTRUMENT SYSTEM
- K792028 — OTOTOME BUR
Data sourced from openFDA. This site is unofficial and independent of the FDA.