DeviceClearance

Product code HRX— Orthopedic

ARTHROSCOPE

Classification name
Arthroscope
Device class
Class 2
Regulation
21 CFR 888.1100
Advisory panel
Orthopedic
Total cleared
683
First cleared
Most recent

FDA classification definition

“Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).”

— U.S. Food and Drug Administration, device classification record for product code HRX under 21 CFR 888.1100, via openFDA

Market context for product code HRX

FDA has cleared 683 devices under product code HRX between 1977 and 2026, filed by 283 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 HRX

Adverse events under product code HRX

product code HRX
Injury
623
Malfunction
11,257
Total
11,880

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 HRX

1–100 of 683

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