510(k) K944067

PEANUT WAND, MODIFICATION by Ideal Medical, Inc. — Product Code GCS

K944067 is an FDA 510(k) premarket notification submitted by Ideal Medical, Inc. for the device "PEANUT WAND, MODIFICATION". The FDA issued a decision of Substantially Equivalent on December 8, 1994. The device falls under product code GCS (Endoscope, Battery-Powered And Accessories), a Class II device regulated under 21 CFR 876.1500. Ideal Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 1994
Date Received
July 26, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscope, Battery-Powered And Accessories
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type