510(k) K771851

ARTHROSCOPE OPERATIVE KNIFE SET by Richard Wolf Medical Instruments Corp. — Product Code HTS

K771851 is an FDA 510(k) premarket notification submitted by Richard Wolf Medical Instruments Corp. for the device "ARTHROSCOPE OPERATIVE KNIFE SET". The FDA issued a decision of Substantially Equivalent on October 27, 1977. The device falls under product code HTS (Knife, Orthopedic), a Class I device regulated under 21 CFR 888.4540. Richard Wolf Medical Instruments Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1977
Date Received
September 29, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Knife, Orthopedic
Device Class
Class I
Regulation Number
888.4540
Review Panel
OR
Submission Type