Arthroscopic Leg Holder 434-21
K834076 is the FDA 510(k) clearance record for ARTHROSCOPIC LEG HOLDER 434-21, a class II device, cleared for Custom Medical Products, Ltd. 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 14 510(k) clearances for Custom Medical Products, Ltd., from to . As of , FDA records show no recalls naming K834076.
Clearance record
- Decision date
- Received
- (32 days to decision)
- Product code
- HRX Arthroscope
- Regulation
- 21 CFR 888.1100
- Device class
- Class II
- Review panel
- Orthopedic
- Applicant
- Custom Medical Products, Ltd. 803 N. Front St. Suite 3, Mchenry IL
- 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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