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FDA 510(k)

FirstFit Surgical Kit

K-Number: K240763 · 2024-12-18

ApplicantFreudenberg Medical, LLC
Decision Date2024-12-18
Product CodeEWL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

FirstFit Surgical Kit is the device name listed in this FDA 510(k) record. The listed applicant is Freudenberg Medical, LLC. It received FDA 510(k) clearance on 2024-12-18 under 510(k) number K240763. The device is classified under product code EWL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FirstFit Surgical Kit?

FirstFit Surgical Kit is a medical device that received FDA 510(k) clearance on 2024-12-18. The listed applicant is Freudenberg Medical, LLC. The 510(k) number is K240763.

When did FirstFit Surgical Kit receive FDA 510(k) clearance?

FirstFit Surgical Kit received FDA 510(k) clearance on 2024-12-18, under 510(k) number K240763.

Who is the listed applicant for FirstFit Surgical Kit?

The FDA 510(k) record lists Freudenberg Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FirstFit Surgical Kit?

The FDA product code for FirstFit Surgical Kit is EWL.

Other records listing Freudenberg Medical, LLC 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.

K192422Steerable Introducer 12FK191190Steerable Introducer

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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