(270 days)
The Micrins Micro Anastomosis Clamp is a hand held surgical instrument that is designed to be used in Microvascular Surgery to either temporarily occlude or approximate blood vessels during the anastomosis process. The clamps are available in three different size ranges and are to be used on vessels that range in size from 0.4mm to 2.25mm. The clamps are used to facilitate surgical procedures that are typically called "free flaps" or replants. Once the microanastomosis has been completed the micro clamp is removed from the patient
The Micrins Micro Anastomosis Clamp is a hand held surgical instrument that is designed to be used in Microvascular Surgery to either temporarily occlude or approximate blood vessels during the anastomosis process. The clamps are available in three different size ranges and are to be used on vessels that range in size from 0.4mm to 2.25mm.
This document is a 510(k) premarket notification letter from the FDA regarding the Micrins Micro Anastomosis Clamp (K982278). It confirms substantial equivalence to predicate devices but does not contain information about acceptance criteria or a study proving device performance.
Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, not on performance data against predefined acceptance criteria.
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).