(43 days)
Permits the safe and simple removal of scalpel blades from most commonly used scalpel handles
Safely contains the blade immediately upon removal, eliminating the need for further handling prior to disposal
The counter allows the user to monitor its use to see when it is becoming full and will need changing
Scalpel handles compatible with the QLICKSMART® include: Swann Morton Blade sizes 3, 4, 7 and 9 Lawton Blade sizes 3 and 4 Martin Blade sizes 3, 4 and 7 Smic Blade sizes 3 and 4 Aesculap Blade sizes 3, 3L, 4 and 7 Sayco Blade sizes 3, 4 and 5 Nopa Blade sizes 3 and 4 Lance Blade sizes 3 and 4 Conqueror Blade size 3 Pro-Med Blade sizes 3 and 4 Paragon Blade sizes 3 and 4 Feather Blade size 7 Rocket Blade size 5 Generic Blade size 4 ab stainless Blade size 4 LRI Blade size 4 Jakobi Blade Size 4
Scalpel handles known to be incompatible with the QLICKSMART® include: Barron Handle Beaver Type Handles Disposable Handles.
Not Found
This document is a marketing authorization letter for the QLICKSMART® scalpel blade remover, not a study report. It states that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has the same intended use and technological characteristics as a device already on the market, or has different technological characteristics but these do not raise new questions of safety and effectiveness.
Therefore, this document does not contain the information requested regarding specific acceptance criteria, device performance metrics, study designs, sample sizes, or ground truth establishment. The FDA letter is a regulatory approval based on demonstrating equivalence, not on the presentation of a de novo clinical or performance study with detailed acceptance criteria and results.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).