510(k) K032601

STRYKER INTERVENTIONAL PAIN RF GENERATOR by Valley Forge Scientific Corp. — Product Code GXD

K032601 is an FDA 510(k) premarket notification submitted by Valley Forge Scientific Corp. for the device "STRYKER INTERVENTIONAL PAIN RF GENERATOR". The FDA issued a decision of Substantially Equivalent on April 1, 2004. The device falls under product code GXD (Generator, Lesion, Radiofrequency), a Class II device regulated under 21 CFR 882.4400. Valley Forge Scientific Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 2004
Date Received
August 25, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, Lesion, Radiofrequency
Device Class
Class II
Regulation Number
882.4400
Review Panel
NE
Submission Type