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510(k) K852402

NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZER by North American Instrument Corp. — Product Code FZX

K852402 is an FDA 510(k) premarket notification submitted by North American Instrument Corp. for the device "NAMIC HOMER MAMMALOK NEEDLE/WIRE LOCALIZER". The FDA issued a decision of Substantially Equivalent on July 11, 1985. The device falls under product code FZX (Guide, Surgical, Instrument), a Class I device regulated under 21 CFR 878.4800. North American Instrument Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 1985
Date Received
June 6, 1985
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 North American Instrument Corp.

  • K960801 — SELECTOR ANGIOGRAPHIC CATHETER (VARIOUS MODELS) (March 29, 1996)
  • K955554 — HEMO-VALVE (March 4, 1996)
  • K960310 — EPIC INTRODUCER SHEATH (February 7, 1996)
  • K922552 — MORSE(R) ANGIOGRAPHIC CATHETERS (March 3, 1993)
  • K915078 — MORSE HEMOSTATIC CATHETER INTRODUCER SET (June 10, 1992)
  • K905208 — MORSE ANESTHESIA (January 10, 1992)
  • K912961 — MORSE VASCULAR INTRODUCER SET (September 11, 1991)
  • K910764 — THE PERCEPTOR(TM) STAND ALONE TRANSDUCER (April 22, 1991)
  • K903493 — NAMIC CONTRAST SAVINGS DELIVERY SYSTEM (March 26, 1991)
  • K904275 — MORSE BALLOON INFLATION DEVICE (January 3, 1991)

Other clearances for product code FZX

  • K914715 — PARALLELING GUIDES (February 16, 1994)
  • K871413 — CIVCO STEPPER (July 14, 1987)
  • K871503 — BIOPSY NEEDLE GUIDE KIT, STERILE (July 10, 1987)
  • K862564 — A.C.L. GUIDE KIT (August 18, 1986)
  • K854262 — MEADOX SURGIMED BREAST LOCALIZATION WIRE SET/ONLY (December 24, 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