510(k) Report

PMA · Approved

Recalled · Class II · 2013

LEGOO

P110003PMAApproved Sep 28, 2011240-day reviewClass IIIRecalls 18

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

Genzyme Corp. · OBC Occluder, Internal Vessel, Temporary

Approved on Sep 28, 2011 through premarket approval, which rests on the device’s own clinical evidence after a 240-day review. It has been recalled 18 times.

Decided
Sep 28, 2011
Review
240 days
Class
Class III
Product code
OBC
Recalls
18

PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.

P110003 has 4 supplements since 2012: changes to the approved device, its labelling or its manufacturing, each approved separately.

PMA supplements approved per year

2012: 32014: 1
2012high 3 (2012) · low 0 (2013)2014
View FIG. 1 as a table
YearSupplements approved
20123
20141
FIG. 1 — Supplements to P110003, 2012–2014Source: FDA PMA database

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

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

Planning a device in OBC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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Does it have a predicate?

PMA decisions do not claim a predicate device.

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 21, 2013Class IIZ-2145-2013Material/Component ContaminationProduct contains particulates (fibers)
Jun 21, 2013Class IIZ-2141-2013Material/Component ContaminationProduct contains particulates (fibers)
Jun 21, 2013Class IIZ-2139-2013Material/Component ContaminationProduct contains particulates (fibers)
Jun 21, 2013Class IIZ-2152-2013Material/Component ContaminationProduct contains particulates (fibers)
Jun 21, 2013Class IIZ-2146-2013Material/Component ContaminationProduct contains particulates (fibers)
Jun 21, 2013Class IIZ-2153-2013Material/Component ContaminationProduct contains particulates (fibers)
Jun 21, 2013Class IIZ-2143-2013Material/Component ContaminationProduct contains particulates (fibers)
Jun 21, 2013Class IIZ-2144-2013Material/Component ContaminationProduct contains particulates (fibers)
Jun 21, 2013Class IIZ-2140-2013Material/Component ContaminationProduct contains particulates (fibers)
Jun 21, 2013Class IIZ-2142-2013Material/Component ContaminationProduct contains particulates (fibers)
Jun 21, 2013Class IIZ-2155-2013Material/Component ContaminationProduct contains particulates (fibers)
Jun 21, 2013Class IIZ-2147-2013Material/Component ContaminationProduct contains particulates (fibers)
Jun 21, 2013Class IIZ-2148-2013Material/Component ContaminationProduct contains particulates (fibers)
Jun 21, 2013Class IIZ-2149-2013Material/Component ContaminationProduct contains particulates (fibers)
Jun 21, 2013Class IIZ-2154-2013Material/Component ContaminationProduct contains particulates (fibers)
Jun 21, 2013Class IIZ-2151-2013Material/Component ContaminationProduct contains particulates (fibers)
Jun 21, 2013Class IIZ-2156-2013Material/Component ContaminationProduct contains particulates (fibers)
Jun 21, 2013Class IIZ-2150-2013Material/Component ContaminationProduct contains particulates (fibers)

The 5 latest of 18 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

How does its category compare?

All OBC devices

OBC Occluder, Internal Vessel, Temporary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · OBC

1in 2014

2011: 12012: 32014: 1
2007high 3 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OBC

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

Recalls per year · OBC

No recall names OBC since 2007.

Adverse event reports per year · OBC

2in 2014

2012: 12013: 52014: 2
2007high 5 (2013) · low 0 (2007)2025

MAUDE reports naming product code OBC, 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—00
20080—00
20090—00
20100—00
20111—00
20123—01
20130—05
20141—02
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Genzyme Corp.

38 FDA decisions under this applicant name. See the company

Recent decisions in OBC

The OBC category page

https://510kreport.com/device/P110003 · printed Nov 6, 2026

Cite this page

510(k) Report. “P110003: LEGOO.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P110003

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