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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 a medical device manufactured by Bolder Surgical, LLC. It received FDA 510(k) clearance on 2021-05-06 under approval 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. It is manufactured by Bolder Surgical, LLC. The 510(k) number is K203640.

When was CoolSeal Reveal approved by the FDA?

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

What company makes CoolSeal Reveal?

CoolSeal Reveal is manufactured by Bolder Surgical, LLC.

What is the FDA product code for CoolSeal Reveal?

The FDA product code for CoolSeal Reveal is GEI.

Other Devices by Bolder Surgical, LLC

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 K211579CoolSeal 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) K231012CoolSeal Trinity

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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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