510(k) K022744

REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS by Medical Device Services — Product Code HWE

K022744 is an FDA 510(k) premarket notification submitted by Medical Device Services for the device "REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS". The FDA issued a decision of Substantially Equivalent on September 18, 2002. The device falls under product code HWE (Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment), a Class I device regulated under 21 CFR 878.4820. Medical Device Services has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 2002
Date Received
August 19, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Device Class
Class I
Regulation Number
878.4820
Review Panel
OR
Submission Type