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510(k) K935457

LOCALIZATION WIRE OR MARKER - SURGICAL by Bip USA, Inc. — Product Code GDF

K935457 is an FDA 510(k) premarket notification submitted by Bip USA, Inc. for the device "LOCALIZATION WIRE OR MARKER - SURGICAL". The FDA issued a decision of Substantially Equivalent on February 17, 1994. The device falls under product code GDF (Guide, Needle, Surgical), 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
February 17, 1994
Date Received
November 12, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Guide, Needle, Surgical
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)
  • K925870 — SPACER (May 19, 1993)
  • K925875 — HORIZONTAL NEEDLE GUIDE ATTACHMENT (April 6, 1993)
  • K925874 — BREAST STABILIZER (March 16, 1993)

Other clearances for product code GDF

  • K031173 — NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 4001 (July 23, 2003)
  • K950311 — GLOBAL MEDICAL PRODUCTS BREST LESION LOCALIZATION NEEDLE WITH STIFFENED WIRE (May 26, 1995)
  • K950007 — SURGICAL INSTRUMENT GUIDE (March 15, 1995)
  • K945124 — BREAST LESION LOCALIZATION NEEDLE (November 22, 1994)
  • K944942 — BREAST LESION LOCALIZATION NEEDLE (November 4, 1994)
  • K935538 — BAUER TEMNO COAXIAL NEEDLE (February 22, 1994)
  • K923840 — NEEDLE-GRABBER (July 13, 1993)
  • K923835 — THE ELEVENTH FINGER (July 9, 1993)
  • K925875 — HORIZONTAL NEEDLE GUIDE ATTACHMENT (April 6, 1993)
  • K924270 — BREAST LESION LOCALIZATION NEEDLE (September 23, 1992)

FDA data resources