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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 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 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. The listed applicant is Bolder Surgical, LLC. The 510(k) number is K203183.

When did CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft) receive FDA 510(k) clearance?

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

Who is the listed applicant for CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft)?

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 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 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)K203640CoolSeal RevealK202114CoolSeal 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.

K261179AlphaTriPart - Monopolar MIC InstrumentsGimmi GmbHK253504Volnewmer™Classys, Inc.K254056THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S (TB-0535FCS); THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S (TB-0520FCS)Olympus Medical Systems Corp.K253484LUTRONIC GENIUSCynosure Lutronic Technology CorporationK251492Irrigation Tubing Bipolar Cord SetNew Deantronics Taiwan , Ltd.K260636Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingStryker Sustainability Solutions

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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