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510(k) K821618

DISPOSABLE NEEDLE HOLDERS by Medcare Products — Product Code FZX

K821618 is an FDA 510(k) premarket notification submitted by Medcare Products for the device "DISPOSABLE NEEDLE HOLDERS". The FDA issued a decision of Substantially Equivalent on June 21, 1982. The device falls under product code FZX (Guide, Surgical, Instrument), a Class I device regulated under 21 CFR 878.4800. Medcare Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 1982
Date Received
June 2, 1982
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 Medcare Products

  • K841122 — TRACHEOSTOMY CARE TRAY (April 25, 1984)
  • K841124 — DIALYSIS TRAY (April 20, 1984)
  • K841123 — DRESSING CHANGE TRAY (April 17, 1984)
  • K831374 — MED CARE PREP RAZOR (October 4, 1983)
  • K831663 — TISSUE FORCEPS (September 26, 1983)
  • K831665 — DISPOSABLE NEEDLE HOLDER (September 12, 1983)
  • K831664 — PLASTIC THUMB FORCEPS (September 12, 1983)
  • K831661 — DISPOSABLE SCISSORS (August 25, 1983)
  • K831662 — DISPOSABLE HEMOSTAT (STRAIGHT&CURVED (July 19, 1983)
  • K823854 — MEDCARE SUTURE REMOVAL TRAYS (March 31, 1983)

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)
  • 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)

FDA data resources