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510(k) K871503

BIOPSY NEEDLE GUIDE KIT, STERILE by Amedic USA — Product Code FZX

K871503 is an FDA 510(k) premarket notification submitted by Amedic USA for the device "BIOPSY NEEDLE GUIDE KIT, STERILE". The FDA issued a decision of Substantially Equivalent on July 10, 1987. The device falls under product code FZX (Guide, Surgical, Instrument), a Class I device regulated under 21 CFR 878.4800. Amedic USA has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 10, 1987
Date Received
April 17, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Guide, Surgical, Instrument
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Amedic USA

  • K897120 — EQUIP COVERS, STERILE (January 4, 1990)
  • K892070 — GENERAL IVT NEEDLE GUIDE KIT, STERILE (September 5, 1989)
  • K892071 — GENERAL (BIOPSY) NEEDLE GUIDE KIT, STERILE (August 8, 1989)
  • K892069 — EXTENDED COVERS, STERILE (August 8, 1989)
  • K892068 — TRT (ACUSON) NEEDLE GUIDE KIT, STERILE (August 4, 1989)
  • K871467 — BIOPSY NEEDLE GUIDE KIT, STERILE (August 21, 1987)
  • K871609 — ULTRASOUND TRANSDUCER SHEATHS, STERILE (July 15, 1987)
  • K871565 — ULTRASOUND TRANSDUCER GEL, STERILE (July 15, 1987)
  • K864219 — TRANSVAGINAL ULTRASOUND BIOPSY NEEDLE GUIDE (March 27, 1987)

Other clearances for product code FZX

  • K914715 — PARALLELING GUIDES (February 16, 1994)
  • K871413 — CIVCO STEPPER (July 14, 1987)
  • K862564 — A.C.L. GUIDE KIT (August 18, 1986)
  • K854262 — MEADOX SURGIMED BREAST LOCALIZATION WIRE SET/ONLY (December 24, 1985)
  • K852402 — NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZER (July 11, 1985)
  • K842698 — BRITISH SPINAL FUSION SET (September 12, 1984)
  • K841618 — THREADING TUBE (August 27, 1984)
  • K841619 — DRILL GUIDE (July 11, 1984)
  • K841297 — TECHMEDICA DRILL GUIDE (April 25, 1984)
  • K840835 — STRAITH DRAIN INSERTER (April 23, 1984)

FDA data resources