510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K001563Substantially Equivalent

Scipro(tm) Flexible Stone Dislodger and Retrieval Set

Scion Cardiovascular, Inc., Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K001563 is the FDA 510(k) clearance record for SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SET, a class II device, cleared for Scion Cardiovascular, Inc. on under FDA product code FGO (Dislodger, Stone, Flexible). FDA records list one 510(k) clearance for Scion Cardiovascular, Inc. As of , FDA records show 2 recalls naming K001563.

Clearance record

Decision date
Received
(187 days to decision)
Product code
FGO Dislodger, Stone, Flexible
Regulation
21 CFR 876.4680
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Scion Cardiovascular, Inc. 14256 SW 119 Ave., Miami FL
510(k) summary
Summary
Third party review
No

Clearances, product code FGO

Trailing 12 months

FDA records hold no clearances under product code FGO in the trailing twelve months.

FDA records show no clearances under product code FGO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FGO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260