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510(k) K952350

JAMSHIDI STYLE BIOPSY NEEDLE (ACRI) (BIOMID), ILLINOIS STYLE BIOPSY NEEDLE (ISAN) by Promedical , Ltd. — Product Code LWE

K952350 is an FDA 510(k) premarket notification submitted by Promedical , Ltd. for the device "JAMSHIDI STYLE BIOPSY NEEDLE (ACRI) (BIOMID), ILLINOIS STYLE BIOPSY NEEDLE (ISAN)". The FDA issued a decision of Substantially Equivalent on July 17, 1995. The device falls under product code LWE (Bone Marrow Collection/Transfusion Kit), a Class II device. Promedical , Ltd. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 1995
Date Received
May 19, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bone Marrow Collection/Transfusion Kit
Device Class
Class II
Regulation Number
Review Panel
HO
Submission Type

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.fda.gov/cdrh/ode/convkit.html.This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Other clearances by Promedical , Ltd.

  • K954596 — PRO-B CORE-RECT COAXIAL BIOPSY SYSTEM (October 7, 1995)
  • K951598 — PRO-B BIOPSY NEEDLE (April 21, 1995)
  • K944944 — CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE (December 21, 1994)
  • K944942 — BREAST LESION LOCALIZATION NEEDLE (November 4, 1994)

Other clearances for product code LWE

  • K913306 — BONE-TEMNO/STERNUM-TEMNO (November 1, 1991)
  • K871198 — BONE MARROW COLLECTION KIT AND STAND (November 6, 1987)

FDA data resources