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Na 22101 a

by Medtronic Powered Surgical Solutions United States GUDID

Product code LKG

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00613994908674 UDI-DIDate17 Jun 2015ListedStatusIn distribution

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls

29 recalls · FDA

  • 29 recalls, same reason

    • Terminated Z-1146-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 via K874498, on the same 510(k)
    • Terminated Z-1128-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 via K874498, on the same 510(k)
    • Terminated Z-1150-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 via K874498, on the same 510(k)
    • Terminated Z-1132-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 via K874498, on the same 510(k)
    • Terminated Z-1124-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 via K874498, on the same 510(k)
    • Terminated Z-1151-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 via K874498, on the same 510(k)
    • Terminated Z-1129-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 via K874498, on the same 510(k)
    • Terminated Z-1149-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 via K874498, on the same 510(k)
    • Terminated Z-1131-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 via K874498, on the same 510(k)
    • Terminated Z-1126-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 via K874498, on the same 510(k)
    • Terminated Z-1135-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 via K874498, on the same 510(k)
    • Terminated Z-1137-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 via K874498, on the same 510(k)
    • Terminated Z-1125-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 via K874498, on the same 510(k)
    • Terminated Z-1139-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 via K874498, on the same 510(k)
    • Terminated Z-1142-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 via K874498, on the same 510(k)
    • Terminated Z-1148-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 via K874498, on the same 510(k)
    • Terminated Z-1144-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 via K874498, on the same 510(k)
    • Terminated Z-1134-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 via K874498, on the same 510(k)
    • Terminated Z-1127-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 via K874498, on the same 510(k)
    • Terminated Z-1143-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 via K874498, on the same 510(k)
    • Terminated Z-1147-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 via K874498, on the same 510(k)
    • Terminated Z-1145-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 via K874498, on the same 510(k)
    • Terminated Z-1141-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 via K874498, on the same 510(k)
    • Terminated Z-1136-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 via K874498, on the same 510(k)
    • Terminated Z-1140-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 via K874498, on the same 510(k)
    • Terminated Z-1138-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 via K874498, on the same 510(k)
    • Terminated Z-1130-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 via K874498, on the same 510(k)
    • Terminated Z-1133-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 via K874498, on the same 510(k)
    • Terminated Z-1152-2009 FDA Unclassified (pre-2012) initiated 12 Feb 2009 via K874498, on the same 510(k)

    The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

GUDID · synced 23 Oct 2026

Trade Name
Na
Generic Name
Cranial port/reservoir
Model / Reference
22101 A
Primary DI / UDI-DI
00613994908674
510(k) Number
FDA Product Code
LKG
GMDN Term
Cranial port/reservoir
Device Class
Class II
Regulation Number
882.5550
Commercial Distribution
In Commercial Distribution
Size
Length — 3.0 Centimeter

Related devices

Category: Cranial port/reservoir

Cleared under the same submission (K874498)

Show all (12)

Other devices from Medtronic Powered Surgical Solutions

See all devices from Medtronic Powered Surgical Solutions →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
Other properties (9)
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No

Sources (1)

  • FDA UDI 0b2a9995-2d41-4fd0-972d-7bdcad356ceb 36 fields · synced 23 Oct 2026