DeviceClearance

Product code ERL— Ear, Nose, Throat

XPS 3000 SYSTEM

Classification name
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Device class
Class 2
Regulation
21 CFR 874.4250
Advisory panel
Ear, Nose, Throat
Total cleared
91
First cleared
Most recent

Market context for product code ERL

FDA has cleared 91 devices under product code ERL between 1978 and 2025, filed by 46 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code ERL

Adverse events under product code ERL

product code ERL
Malfunction
11,234
Total
11,234

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 ERL

Data sourced from openFDA. This site is unofficial and independent of the FDA.