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510(k) K820170

MED-CARE EMERGENCY SHEARS by Medcare Products — Product Code FZT

K820170 is an FDA 510(k) premarket notification submitted by Medcare Products for the device "MED-CARE EMERGENCY SHEARS". The FDA issued a decision of Substantially Equivalent on February 5, 1982. The device falls under product code FZT (Cutter, Surgical), 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
February 5, 1982
Date Received
January 21, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cutter, Surgical
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)
  • K831664 — PLASTIC THUMB FORCEPS (September 12, 1983)
  • K831665 — DISPOSABLE NEEDLE HOLDER (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 FZT

  • K112400 — SMARTSHEARS (September 12, 2011)
  • K890818 — AUTO SUTURE DISPOSABLE SURGICAL TROCAR* (May 4, 1989)
  • K872990 — MICRINS SURGICAL SCISSOR (August 17, 1987)
  • K841741 — SINGLE HAIR TRANSPLANT GRAFT (July 23, 1984)
  • K841247 — SPC DISPOSABLE CUTTER (May 2, 1984)
  • K822448 — SCISSORS, VARIOUS (September 14, 1982)
  • K821632 — SURGICAL SCISSORS, SET OF 3 (June 24, 1982)
  • K821350 — CONPHAR WIRE CUTTING SCISSORS (May 27, 1982)
  • K821361 — CONPHAR TONSIL SCISSORS (May 27, 1982)
  • K821352 — CONPHAR IRIS SCISSORS (May 27, 1982)

FDA data resources