Home / 510(k) Clearances / K021702

510(k) K021702

CRYOBAG, MODEL CB by Origen Biomedical, Inc. — Product Code LPZ

K021702 is an FDA 510(k) premarket notification submitted by Origen Biomedical, Inc. for the device "CRYOBAG, MODEL CB". The FDA issued a decision of Substantially Equivalent on August 6, 2002. The device falls under product code LPZ (Container, Frozen Donor Tissue Storage), a Class U device. Origen Biomedical, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 2002
Date Received
May 23, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Container, Frozen Donor Tissue Storage
Device Class
Class U
Regulation Number
Review Panel
HO
Submission Type

Other clearances by Origen Biomedical, Inc.

  • K113869 — ORIGEN REINFORCED DUAL LUMEN CATHETER (July 26, 2012)
  • K003288 — ORIGEN DUAL LUMEN CATHETER (June 8, 2001)
  • K003145 — ORIGEN BLADDER HOLDER (April 20, 2001)

Other clearances for product code LPZ

  • K915471 — CRYOBAG (March 2, 1994)
  • K863872 — TAMPER HAMPER (February 10, 1987)
  • K861761 — ACCESSUS DRY STORAGE PACKAGE STERILE COMP STORAGE (August 28, 1986)
  • K860511 — AMPU-PAK (August 4, 1986)
  • K853663 — ACCESSUS CRYOPRESERVATION PKG. STERILE TISSUE STOR (April 9, 1986)

FDA data resources