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510(k) K925870

SPACER by Bip USA, Inc. — Product Code MJG

K925870 is an FDA 510(k) premarket notification submitted by Bip USA, Inc. for the device "SPACER". The FDA issued a decision of Substantially Equivalent on May 19, 1993. The device falls under product code MJG (Device, Percutaneous, Biopsy), a Class I device regulated under 21 CFR 878.4800. Bip USA, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 1993
Date Received
November 19, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Percutaneous, Biopsy
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Bip USA, Inc.

  • K024089 — VACUFLASH BIOPSY SYSTEM (March 11, 2003)
  • K934371 — BIP MULTI MODIFICATION (April 28, 1994)
  • K934370 — BIP BIOPSY NEEDLE MODIFICATION (March 7, 1994)
  • K935457 — LOCALIZATION WIRE OR MARKER - SURGICAL (February 17, 1994)
  • K925875 — HORIZONTAL NEEDLE GUIDE ATTACHMENT (April 6, 1993)
  • K925874 — BREAST STABILIZER (March 16, 1993)

Other clearances for product code MJG

  • K080674 — PAJUNK'S PRIMOCUT DISPOSABLE BIOPSY SYSTEM (May 9, 2008)
  • K070836 — EXICLIP EXCS-M (April 20, 2007)
  • K983647 — ECHO-COAT ULTRASOUND NEEDLES (January 20, 1999)
  • K955683 — RNS STERILE, DISPOSABLE BREAST BIOPSY/LOCALIZATION TRAY (February 1, 1996)
  • K933324 — SKIN BIOPSY DEVICE (March 31, 1994)
  • K922919 — DYNACYT BIOPSY ASPIRATION DEVICE (March 31, 1993)

FDA data resources