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510(k) K112400

SMARTSHEARS by Nuscience Consulting and Management Group, LLC — Product Code FZT

K112400 is an FDA 510(k) premarket notification submitted by Nuscience Consulting and Management Group, LLC for the device "SMARTSHEARS". The FDA issued a decision of Substantially Equivalent on September 12, 2011. The device falls under product code FZT (Cutter, Surgical), a Class I device regulated under 21 CFR 878.4800.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2011
Date Received
August 19, 2011
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 for product code FZT

  • 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)
  • K821352 — CONPHAR IRIS SCISSORS (May 27, 1982)
  • K821361 — CONPHAR TONSIL SCISSORS (May 27, 1982)
  • K821355 — CONPHAR LITTAUER SCISSORS (May 27, 1982)
  • K821350 — CONPHAR WIRE CUTTING SCISSORS (May 27, 1982)

FDA data resources