About this document
CORE-Trocar 510(k) Summary K211148 by jsiddh30 is a document available to read on EtoBox.
The FDA has determined that the CORE-Trocar device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed under the general controls provisions of the Federal Food, Drug, and Cosmetic Act. The CORE-Trocar is a single-use medical device designed for endoscopic procedures, with various models available, and has passed safety and performance tests, including sterility and biocompatibility. Compliance with all regulatory requirements, including labeling and good manufactur
- Author
- jsiddh30
- Language
- EN