510(k) K873387
K873387 is an FDA 510(k) premarket notification submitted by Arthropedics, Inc. for the device "VIDEO ARTHROSCOPE, 1.7MM X 55 MM". The FDA issued a decision of Substantially Equivalent on November 25, 1987. The device falls under product code HXR (Spatula, Orthopedic), a Class I device regulated under 21 CFR 878.4800. Arthropedics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 25, 1987
- Date Received
- June 26, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Spatula, Orthopedic
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type