510(k) K863696

ARTHROSCOPIC SURGICAL POWER DEVICE by American Edwards Laboratories — Product Code KIT

K863696 is an FDA 510(k) premarket notification submitted by American Edwards Laboratories for the device "ARTHROSCOPIC SURGICAL POWER DEVICE". The FDA issued a decision of Substantially Equivalent on September 29, 1986. The device falls under product code KIT (Media And Components, Synthetic Cell And Tissue Culture), a Class I device regulated under 21 CFR 864.2220. American Edwards Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 1986
Date Received
September 22, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media And Components, Synthetic Cell And Tissue Culture
Device Class
Class I
Regulation Number
864.2220
Review Panel
PA
Submission Type