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Single Use Preloaded Sphincterotome V KD-V631M-07301S

by Olympus Medical Systems Corporation EUDAMEDGUDID

Active European Union

Ref N5787830

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04953170403200 Basic UDI-DIDate5 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04953170403200 UDI-DIDate5 Jan 2018ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

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 on record, checked 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Single Use Preloaded Sphincterotome V KD-V631M-07301S EUDAMED
Single Use Preloaded Sphincterotome V GUDID
Generic Name
Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
Device Name
Single Use Sphincterotome/ Needle knife
Model / Ref / Catalog
N5787830, KD-V631M-07301S
Primary DI / UDI-DI
04953170403200
Basic UDI-DI
B-04953170403200
FDA Product Code
KNS
EMDN Code
G03040202 Papillotomes / sphincterotomes, triple (or more) lumen
GMDN Term
Endoscopic electrosurgical handpiece/electrode, monopolar, single-use
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
876.4300
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
N5787830
GUDID
KD-V631M-07301S
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: Endoscopic electrosurgical handpiece/electrode, monopolar, single-use

Other devices from Olympus Medical Systems Corporation

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Properties

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

Other properties (19)

  • 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
  • Manufacturing Date: No