Mitek Arthroscopes
510(k) K133941
Mitek Arthroscopes is a medical device (FDA Class II; FDA product code HRX, Arthroscope) made by Medos International SARL, cleared under FDA 510(k) K133941 on 18 Apr 2014, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK133941 | Date18 Apr 2014 | StatusActive |
Official records
- FDA 510(k) database K133941
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HRX
- Device class
- Class II
- Regulation
- 21 CFR Part 888.1100
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code HRX (Arthroscope).
- I.M. ARTHROSCOPE by Instrument Makar, Inc.
- DCI ENDOSCOPE by Karl Storz Endoscopy-America, Inc.
- INNERVUE DIAGNOSTIC SCOPE SYSTEM by Biomet Orthopedics, Inc.
- ACUFEX ARTHROSCOPE by Acufex Microsurgical, Inc.
- MEDINAUT Plus Kyphoplasty System MPU2-B1D1MN2-20 by IMEDICOM CO., LTD.
- AMD SYSTEM WORKING CHANNEL SCOPE AND ACCESSORIES by Smith & Nephew Richards, Inc.
- FLEXPOSURE RETRACTOR by Endius, Inc.
- DANEK RIGID ARTHROSCOPE by Sofamor Danek USA, Inc.
- KARL STORZ KNIVES, CURETTS, HOOKS, PROBES by Karl Storz Endoscopy-America, Inc.
- MEDISISS REPROCESSED ARTHROSCOPIC SHAVERS AND BURS by Medisiss