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FDA 510(k)

CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft)

K-Number: K203183 · 2021-05-06

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

Device Summary

CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft) is a medical device manufactured by Bolder Surgical, LLC. It received FDA 510(k) clearance on 2021-05-06 under approval number K203183. 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 Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft)?

CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft) 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 K203183.

When was CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft) approved by the FDA?

CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft) received FDA 510(k) clearance on 2021-05-06, under approval number K203183.

What company makes CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft)?

CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft) is manufactured by Bolder Surgical, LLC.

What is the FDA product code for CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft)?

The FDA product code for CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft) 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) K203640CoolSeal Reveal 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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