Skip to content

Extractor™

by Boston Scientific Corporation 18 variants

Ref M00547050

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None ongoing

3 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K970052↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number01915060000000000000239N5 Basic UDI-DI 08714729790303UDI-DIDate31 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number08714729790303 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK970052 Date25 Mar 1997IssuedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

3 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-0553-03 FDA Unclassified (pre-2012) initiated 29 Jan 2003 on shared 510(k) K970052
    • Terminated Z-0551-03 FDA Unclassified (pre-2012) initiated 29 Jan 2003 on shared 510(k) K970052
    • Terminated Z-0552-03 FDA Unclassified (pre-2012) initiated 29 Jan 2003 on shared 510(k) K970052

    Breach in sterile barrrier may compromise sterility

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k) · GUDID

Trade Name
Extractor™ EUDAMED
Extractor™ Pro RX GUDID
Generic Name
ERCP catheter, balloon, non-electrical, stone-retrieval
Model / Reference
M00547050
Primary DI / UDI-DI
08714729790303
Basic UDI-DI
01915060000000000000239N5
FDA Product Code
FGE
EMDN Code
G03050101 Digestive endoscopy, retrieval balloon devices
GMDN Term
ERCP catheter, balloon, non-electrical, stone-retrieval
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
876.5010
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000004702
Authorised representative
Boston Scientific Limited IE-AR-000003840

Other devices from Boston Scientific

See all devices from Boston Scientific →

Properties

  • Sterile
  • Single Use
  • Contains Latex
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (18)

  • Implantable: No
  • Reusable: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No