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Lead Adaptor BIS/BIS-40

by Oscor Inc.

Ref BIS/BIS-40

Lead Adaptor BIS/BIS-40 is a device classified as Class III in the EU and Class II in the US made by Oscor Inc., registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI B-00885672008369), cleared under FDA 510(k) K010787 on 22 May 2001 and listed in FDA GUDID since 27 Nov 2017 (UDI-DI 00885672008369), active as of 7 Nov 2026.

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

CE MDD 510(k)

Valid until

No date given

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

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K010787

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00885672008369 Basic UDI-DI 00885672008369UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00885672008369 UDI-DI Date27 Nov 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK010787 Date22 May 2001DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00885672008369 registered 30 Oct 2026 Active
  • FDA 510(k) K010787 decided 22 May 2001 Active
  • FDA GUDID UDI-DI 00885672008369 listed 27 Nov 2017 Listed

Recalls

1 recall · FDA

    • Terminated Z-2333-2008 FDA Unclassified (pre-2012) initiated 29 Jan 2008 on shared 510(k) K010787

    The O-rings are over tolerance making it hard to connect the leads to the pacemaker.

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

Timeline

4 dated events

  1. Cleared FDA 510(k) K010787
  2. Recall initiated FDA recalls Z-2333-2008
  3. Listed FDA GUDID 00885672008369
  4. Registered EUDAMED B-00885672008369

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Adaptor EUDAMED
Lead Adaptor GUDID
Generic name
Pacing/defibrillation lead electrical adaptor
Model / Ref / Catalog
BIS/BIS-40
Primary DI / UDI-DI
00885672008369
Basic UDI-DI
B-00885672008369
510(k) Number
FDA product code
DTD
EMDN code
J01900180 Permanent cardiac leads - accessories
GMDN term
Pacing/defibrillation lead electrical adaptor
Device class
Class III EUDAMED
Class II GUDID
Regulation number
870.3620
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Length — 40 Centimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
Class II

Device class is stated on each registry's own scale: Class III in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Pacing/defibrillation lead electrical adaptor

Cleared under the same submission (K010787)

Similar devices in this category

Other devices filed under PERMANENT CARDIAC LEADS - ACCESSORIES.

Other devices from Oscor Inc.

See all devices from Oscor Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (17, all answered No)