510(k) K012624
K012624 is an FDA 510(k) premarket notification submitted by Medical Instruments Technology, Inc. for the device "REPROCESSED ARTHROSCOPIC BLADES, ARTHROSCOPIC SHAVERS, SHAVER BLADE, BLADE, LIMITED REUSE BLADE, ARTHROSCOPIC BURS". The FDA issued a decision of Substantially Equivalent on November 8, 2001. The device falls under product code HRX (Arthroscope), a Class II device regulated under 21 CFR 888.1100. Medical Instruments Technology, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 8, 2001
- Date Received
- August 13, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Arthroscope
- Device Class
- Class II
- Regulation Number
- 888.1100
- Review Panel
- OR
- Submission Type
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).