510(k) K251807

Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR by Olympus Medical Systems Corp. — Product Code KGE

K251807 is an FDA 510(k) premarket notification submitted by Olympus Medical Systems Corp. for the device "Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR". The FDA issued a decision of Substantially Equivalent on March 6, 2026. The device falls under product code KGE (Forceps, Biopsy, Electric), a Class II device regulated under 21 CFR 876.4300. Olympus Medical Systems Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 2026
Date Received
June 12, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Forceps, Biopsy, Electric
Device Class
Class II
Regulation Number
876.4300
Review Panel
GU
Submission Type