510(k) K243807

Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P by Olympus Medical Systems Corp. — Product Code LQR

K243807 is an FDA 510(k) premarket notification submitted by Olympus Medical Systems Corp. for the device "Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P". The FDA issued a decision of Substantially Equivalent on March 18, 2025. The device falls under product code LQR (Dislodger, Stone, Biliary), a Class II device regulated under 21 CFR 876.5010. Olympus Medical Systems Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 2025
Date Received
December 11, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dislodger, Stone, Biliary
Device Class
Class II
Regulation Number
876.5010
Review Panel
GU
Submission Type