GREY:TSTIF - Post by User
Comment by
elgin1on Sep 28, 2017 9:50am
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Post# 26752869
RE:RE:FDA/TOS
RE:RE:FDA/TOSThe way this is going seems like Pentax is moving a lot faster than Olympus in responding to end cap issue and possible source of contamination. Since Pentax already has a new modified scope out before the August 8 deadline, I believe they might start eating into Olympus market . Olympus will have to redesign its end cap and submit a new 510 k using VP4 which will take time.
I wonder why FDA did not just give the new Pentax scope approval for sterilization alone in the meanwhile while asking for data for all the other damaged scopes in the field?
Elgin