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FDA 510(k)

Saffron Fixation System

K-Number: K220420 · 2022-06-10

ApplicantColoplast A/S
Decision Date2022-06-10
Product CodePBQ
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Saffron Fixation System is a medical device manufactured by Coloplast A/S. It received FDA 510(k) clearance on 2022-06-10 under approval number K220420. The device is classified under product code PBQ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Saffron Fixation System?

Saffron Fixation System is a medical device that received FDA 510(k) clearance on 2022-06-10. It is manufactured by Coloplast A/S. The 510(k) number is K220420.

When was Saffron Fixation System approved by the FDA?

Saffron Fixation System received FDA 510(k) clearance on 2022-06-10, under approval number K220420.

What company makes Saffron Fixation System?

Saffron Fixation System is manufactured by Coloplast A/S.

What is the FDA product code for Saffron Fixation System?

The FDA product code for Saffron Fixation System is PBQ.

Related Clinical Trials

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Other Devices by Coloplast A/S

K181811ReTrace Ureteral Access Sheath K173527Digitex Delivery Device K191536Biatain Silicone Ag K221874Altis Single Incision Sling System

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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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