← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

HRX — Arthroscope

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).

DEVICE CLASS
Class II
REGULATION
21 CFR 888.1100
MEDICAL SPECIALTY
Orthopedic
REVIEW PANEL
OR
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
14
510(K)/PMA CLEARANCES
510k: 14
0
RECALL ENTRIES

Recent clearances

K252790Clarus Medical, LLC · 510k2026-05-26
K253523Spinal Simplicity · 510k2026-04-16
K252546Allevion Medical, LLC · 510k2026-03-12
K253217Medimaging Integrated Solution, Inc (Miis) · 510k2025-12-23
K250795W.O.M. World of Medicine GmbH · 510k2025-12-05
K252666Joint Preservation Innovations, LLC · 510k2025-11-21
K252458Shanghai Lange Medtech Co., Ltd. · 510k2025-11-03
K252020Hand Biomechanics Lab, Inc. · 510k2025-10-15

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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