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FDA 510(k)

CoolSeal Generator® (CSL-200-90)

K-Number: K253634 · 2026-06-17

ApplicantHologic, Inc.
Decision Date2026-06-17
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CoolSeal Generator® (CSL-200-90) is the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2026-06-17 under 510(k) number K253634. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CoolSeal Generator® (CSL-200-90)?

CoolSeal Generator® (CSL-200-90) is a medical device that received FDA 510(k) clearance on 2026-06-17. The listed applicant is Hologic, Inc.. The 510(k) number is K253634.

When did CoolSeal Generator® (CSL-200-90) receive FDA 510(k) clearance?

CoolSeal Generator® (CSL-200-90) received FDA 510(k) clearance on 2026-06-17, under 510(k) number K253634.

Who is the listed applicant for CoolSeal Generator® (CSL-200-90)?

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

What is the FDA product code for CoolSeal Generator® (CSL-200-90)?

The FDA product code for CoolSeal Generator® (CSL-200-90) is GEI.

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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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