510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K203183Substantially Equivalent

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

Bolder Surgical, LLC, Louisville CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K203183 is the FDA 510(k) clearance record for CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft), a class II device, cleared for Bolder Surgical, LLC on under FDA product code GEI (Electrosurgical, Cutting & Coagulation & Accessories). FDA's definition for product code GEI reads: "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...". FDA records list 8 510(k) clearances for Bolder Surgical, LLC, from to . As of , FDA records show no recalls naming K203183.

Clearance record

Decision date
Received
(191 days to decision)
Product code
GEI Electrosurgical, Cutting & Coagulation & Accessories
Regulation
21 CFR 878.4400
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Bolder Surgical, LLC 331 S. 104th St., Louisville CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GEI

Trailing 12 months
47 clearances under product code GEI in the twelve months to October 2026, June 2026 the highest month at 9.
Show the numbers
Monthly 510(k) clearances under FDA product code GEI, trailing twelve months
MonthClearances
November 20254
December 20251
January 20266
February 20263
March 20265
April 20265
May 20264
June 20269
July 20263
August 20262
September 20265
October 20260