510(k) K952463

GS & GS20 SURGICAL TOOL SYSTEM by Midas Rex Pneumatic Tools, Inc. — Product Code GET

K952463 is an FDA 510(k) premarket notification submitted by Midas Rex Pneumatic Tools, Inc. for the device "GS & GS20 SURGICAL TOOL SYSTEM". The FDA issued a decision of Substantially Equivalent on July 17, 1995. The device falls under product code GET (Motor, Surgical Instrument, Pneumatic Powered), a Class I device regulated under 21 CFR 878.4820. Midas Rex Pneumatic Tools, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 1995
Date Received
May 26, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Motor, Surgical Instrument, Pneumatic Powered
Device Class
Class I
Regulation Number
878.4820
Review Panel
SU
Submission Type