Reprocessed Arthroscopic Blades, Arthroscopic Shavers, Shaver Blade, Blade, Limited Reuse Blade, Arthroscopic Burs
K012624 is the FDA 510(k) clearance record for REPROCESSED ARTHROSCOPIC BLADES, ARTHROSCOPIC SHAVERS, SHAVER BLADE, BLADE, LIMITED REUSE BLADE, ARTHROSCOPIC BURS, a class II device, cleared for Medical Instruments Technology, Inc. on under FDA product code HRX (Arthroscope). FDA's definition for product code HRX reads: "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...". FDA records list 5 510(k) clearances for Medical Instruments Technology, Inc., from to . As of , FDA records show no recalls naming K012624.
Clearance record
- Decision date
- Received
- (87 days to decision)
- Product code
- HRX Arthroscope
- Regulation
- 21 CFR 888.1100
- Device class
- Class II
- Review panel
- Orthopedic
- Applicant
- Medical Instruments Technology, Inc. 385 N. 3050 E., St. George UT
- 510(k) summary
- Summary
- Third party review
- No
Clearances, product code HRX
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 2 |
| December 2025 | 2 |
| January 2026 | 0 |
| February 2026 | 0 |
| March 2026 | 1 |
| April 2026 | 1 |
| May 2026 | 1 |
| June 2026 | 0 |
| July 2026 | 0 |
| August 2026 | 2 |
| September 2026 | 0 |
| October 2026 | 0 |
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