510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K112400Substantially Equivalent

Smartshears

Nuscience Consulting and Management Group, LLC, Fleming Island FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K112400 is the FDA 510(k) clearance record for SMARTSHEARS, a class I device, cleared for Nuscience Consulting and Management Group, LLC on under FDA product code FZT (Cutter, Surgical). FDA records list one 510(k) clearance for Nuscience Consulting and Management Group, LLC. As of , FDA records show no recalls naming K112400.

Clearance record

Decision date
Received
(24 days to decision)
Product code
FZT Cutter, Surgical
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Nuscience Consulting and Management Group, LLC P.O. Box 8507, Fleming Island FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FZT

Trailing 12 months

FDA records hold no clearances under product code FZT in the trailing twelve months.

FDA records show no clearances under product code FZT in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FZT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260