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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Institut Straumann AG. It received FDA 510(k) clearance on 2018-06-21 under 510(k) 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. The listed applicant is Institut Straumann AG. The 510(k) number is K180791.

When did Straumann BLX Surgical Cassette receive FDA 510(k) clearance?

Straumann BLX Surgical Cassette received FDA 510(k) clearance on 2018-06-21, under 510(k) number K180791.

Who is the listed applicant for Straumann BLX Surgical Cassette?

The FDA 510(k) record lists Institut Straumann AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Straumann BLX Surgical Cassette?

The FDA product code for Straumann BLX Surgical Cassette is KCT.

Other records listing Institut Straumann AG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: KCT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253187SteriBest® Sterilization Tray SystemMastel SurgicalK260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AGK252854SteriTite Container System with MediTray ProductsCase Medical, Inc.K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc.K251614Stainless Steel Surgical KitsDentsply Sirona, Inc.K251756Sterilization TraysParagon Implant Mfg., LLC

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.

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