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FDA 510(k)

CoolSeal Reveal

K-Number: K203640 · 2021-05-06

ApplicantBolder Surgical, LLC
Decision Date2021-05-06
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CoolSeal Reveal is the device name listed in this FDA 510(k) record. The listed applicant is Bolder Surgical, LLC. It received FDA 510(k) clearance on 2021-05-06 under 510(k) number K203640. 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 Reveal?

CoolSeal Reveal is a medical device that received FDA 510(k) clearance on 2021-05-06. The listed applicant is Bolder Surgical, LLC. The 510(k) number is K203640.

When did CoolSeal Reveal receive FDA 510(k) clearance?

CoolSeal Reveal received FDA 510(k) clearance on 2021-05-06, under 510(k) number K203640.

Who is the listed applicant for CoolSeal Reveal?

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

What is the FDA product code for CoolSeal Reveal?

The FDA product code for CoolSeal Reveal is GEI.

Other records listing Bolder Surgical, 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.

K231012CoolSeal TrinityK211579CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft)K203183CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft)K202114CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft)/CSL-TR105-30, CoolSeal Trinity (37 cm shaft)/CSL-TR105-37, CoolSeal Trinity (44 cm shaft)/CSL-TR105-44, CoolSeal Mini (20cm shaft)/CSL-MN103-20

Related Devices (Code: GEI)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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