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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 the device name listed in this FDA 510(k) record. The listed applicant is Coloplast A/S. It received FDA 510(k) clearance on 2022-06-10 under 510(k) 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. The listed applicant is Coloplast A/S. The 510(k) number is K220420.

When did Saffron Fixation System receive FDA 510(k) clearance?

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

Who is the listed applicant for Saffron Fixation System?

The FDA 510(k) record lists Coloplast A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Saffron Fixation System?

The FDA product code for Saffron Fixation System is PBQ.

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Related Devices (Code: PBQ)

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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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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