Straumann BLX Surgical Cassette
K-Number: K180791 · 2018-06-21
ApplicantInstitut Straumann AG
Decision Date2018-06-21
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Straumann BLX Surgical Cassette is a medical device manufactured by Institut Straumann AG. It received FDA 510(k) clearance on 2018-06-21 under approval number K180791. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Straumann BLX Surgical Cassette?
Straumann BLX Surgical Cassette is a medical device that received FDA 510(k) clearance on 2018-06-21. It is manufactured by Institut Straumann AG. The 510(k) number is K180791.
When was Straumann BLX Surgical Cassette approved by the FDA?
Straumann BLX Surgical Cassette received FDA 510(k) clearance on 2018-06-21, under approval number K180791.
What company makes Straumann BLX Surgical Cassette?
Straumann BLX Surgical Cassette is manufactured by Institut Straumann AG.
What is the FDA product code for Straumann BLX Surgical Cassette?
The FDA product code for Straumann BLX Surgical Cassette is KCT.
Related Clinical Trials
Other Devices by Institut Straumann AG
Related Devices (Code: KCT)
K160574K3PRO SURGICAL TRAYArgon Med. Productions Vertriebs Gesellschaft Mbh CO KG
K162600Jewel Precision Reusable Rigid Sterilization Container SystemJewel Precision Sheet Metal & Machine, Inc.
K160912Sterilization TraySTERIS Corporation
K161347Signia sterilization trayCovidien
K152745ReNew Sterilization Trays(Catalog #3708 and #3709)Microline Surgical, Inc.
K152111Symmetry Surgical Quad-Lock Container SystemSymmetry Surgical, Inc.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.