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SureTome™ SW Sphincterotome with DomeTip®

by Wilson-Cook Medical, Inc. 2 variants

Ref SUR-SW-35

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0827002WCM00000000048N4 Basic UDI-DI 00827002613508UDI-DIDate20 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00827002613508 UDI-DI Date8 Dec 2025ListedStatusListed GUDID: in commercial distribution

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

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
SureTome™ SW Sphincterotome with DomeTip® EUDAMED
SureTome SW GUDID
Generic Name
Endoscopic electrosurgical handpiece/electrode, bipolar, single-use
Device Name
Sphincterotomes
Model / Ref / Catalog
SUR-SW-35, G61350
Primary DI / UDI-DI
00827002613508
Basic UDI-DI
0827002WCM00000000048N4
510(k) Number
FDA Product Code
KNS
EMDN Code
G03040202 Papillotomes / sphincterotomes, triple (or more) lumen
GMDN Term
Endoscopic electrosurgical handpiece/electrode, bipolar, single-use
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
876.4300
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
SUR-SW-35
GUDID
G61350
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000002658
Authorised representative
COOK MEDICAL EUROPE LIMITED IE-AR-000000907

Other devices from Wilson-Cook Medical, Inc.

See all devices from Wilson-Cook Medical, Inc. →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • Implantable: No
  • Reusable: No
  • Contains Latex: 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