510(k) Report

510(k) · Cleared

Recalled · 2003

Scipro (TM) Flexible Stone Dislodger and Retrieval Set

K001563510(k) TraditionalCleared Nov 22, 2000187-day reviewClass II21 CFR 876.4680Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Scion Cardiovascular, Inc. · FGO Dislodger, Stone, Flexible

Cleared on Nov 22, 2000 after a 187-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 2 times.

Decided
Nov 22, 2000
Review
187 days
Class
Class II
Product code
FGO
Recalls
2
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K001563Source: FDA 510(k) database · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jun 30, 2003Not classifiedZ-0557-04OtherThe firm received field complaints that it was difficult to open the stone retrieval basket during use.
May 23, 2003Not classifiedZ-0554-04OtherPossible difficulty for the user in opening the stone retrieval basket.

No ancestor or descendant has a Class I recall.

How does its category compare?

All FGO devices

FGO Dislodger, Stone, Flexible: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FGO

FDA has decided no FGO device since 2007.

Median 510(k) review, days · FGO

Too few FGO 510(k)s in any year since 2007 to give a median.

Recalls per year · FGO

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FGO

10in 2025

2007: 22008: 232009: 322010: 112011: 152012: 132013: 152014: 42015: 152016: 212017: 172018: 142019: 252020: 192021: 142022: 182023: 142024: 192025: 10
2007high 32 (2009) · low 2 (2007)2025

MAUDE reports naming product code FGO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—02
20080—023
20090—032
20100—011
20110—115
20120—013
20130—015
20140—04
20150—015
20160—021
20170—017
20180—014
20190—025
20200—019
20210—014
20220—018
20230—014
20240—019
20250—010
20260—0—

Recent decisions in FGO

The FGO category page

  • K970121Stone Dislodger, BasketBoston Scientific Corp · 1997
  • K963750Retrieval SnareBoston Scientific Corp · 1996
  • K962676Disposable Endoscopic Retrieval DeviceUnited States Endoscopy Group, Inc. · 19962 recalls
  • K951309Stone Dislodger, BasketBoston Scientific Corp · 1995
  • K933261Grasping ForcepsSurgitek · 1994

https://510kreport.com/device/K001563 · printed Nov 5, 2026

Cite this page

510(k) Report. “K001563: Scipro (TM) Flexible Stone Dislodger and Retrieval Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K001563

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026