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Lead Adaptor BISX2-52

by Oscor Inc.

Lead Adaptor BISX2-52 is a Class II device made by Oscor Inc., cleared under FDA 510(k) K010787 on 22 May 2001 and listed in FDA GUDID since 27 Nov 2017 (UDI-DI 00836559005544), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K010787

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00836559005544 UDI-DI Date27 Nov 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK010787 Date22 May 2001DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K010787 decided 22 May 2001 Active
  • FDA GUDID UDI-DI 00836559005544 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

3 dated events

  1. Cleared FDA 510(k) K010787
  2. Recall initiated FDA recalls Z-2333-2008
  3. Listed FDA GUDID 00836559005544

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Lead Adaptor
Generic name
Pacing/defibrillation lead electrical adaptor
Model / Ref / Catalog
BISX2-52
Primary DI / UDI-DI
00836559005544
510(k) Number
FDA product code
DTD
GMDN term
Pacing/defibrillation lead electrical adaptor
Device class
Class II
Regulation number
870.3620
GUDID distribution status
In Commercial Distribution
Size
Length — 52 Centimeter

Related devices

Category: Pacing/defibrillation lead electrical adaptor

Cleared under the same submission (K010787)

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 (7, all answered No)