Cleared Traditional

K211579 - CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft)

K211579 is an FDA 510(k) clearance for CoolSeal Trinity (30 cm shaft), manufactured by Bolder Surgical, LLC. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K211579 · Bolder Surgical, LLC · General & Plastic Surgery device
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Sep 2021
Decision
109d
Days
Class 2
Risk

K211579 is an FDA 510(k) clearance for the CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trin.... Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Bolder Surgical, LLC (Louisville, US). The FDA issued a Cleared decision on September 7, 2021 after a review of 109 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Bolder Surgical, LLC devices

FDA 510(k) Submission Details - K211579

510(k) Number K211579 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2021
Decision Date September 07, 2021
Days to Decision 109 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 115d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEI Device Classification - Class 2, Special Controls

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GEI Electrosurgical, Cutting & Coagulation & Accessories

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