510(k) K863273

MARTIN MEDICAL PRO-SCOPE ANOSCOPE by Martin Medical — Product Code KOA

K863273 is an FDA 510(k) premarket notification submitted by Martin Medical for the device "MARTIN MEDICAL PRO-SCOPE ANOSCOPE". The FDA issued a decision of Substantially Equivalent on November 4, 1986. The device falls under product code KOA (Surgical Instruments, G-U, Manual (And Accessories)), a Class I device regulated under 21 CFR 876.4730. Martin Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 1986
Date Received
August 25, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Surgical Instruments, G-U, Manual (And Accessories)
Device Class
Class I
Regulation Number
876.4730
Review Panel
GU
Submission Type