Cleared Traditional

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

K203183 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 191-day FDA review.

K203183 · Bolder Surgical, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2021
Decision
191d
Days
Class 2
Risk

K203183 is an FDA 510(k) clearance for the CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft). 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 May 6, 2021 after a review of 191 days - an extended review cycle.

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 - K203183

510(k) Number K203183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2020
Decision Date May 06, 2021
Days to Decision 191 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
76d slower than avg
Panel avg: 115d · This submission: 191d
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

All 2002
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K203183.
Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis Wand
K210423 · ArthroCare Corporation · Jun 2021
Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and Divider, Double Action
K203682 · Olympus Winter & Ibe GmbH · May 2021
MicroFrance Monopolar and Bipolar Electrosurgical Instruments
K210942 · Integra Microfrance · May 2021
CoolSeal Reveal
K203640 · Bolder Surgical, LLC · May 2021
ArtiSential Laparoscopic Instruments-Electrodes
K203580 · Livsmed, Inc. · Apr 2021
Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps
K203277 · Olympus Winter & Ibe GmbH · Apr 2021