BOLDER SURGICAL, LLC

FDA Device Registration & Listing · LOUISVILLE, CO, US · Registration 3010377594

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3010377594
FEI Number
3010377594
Entity Name
BOLDER SURGICAL, LLC
City/State/Country
LOUISVILLE, CO, US
Establishment Address
331 S. 104th Street, Suite 200, LOUISVILLE, CO 80027, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
HOLOGIC, INC. (Owner Number: 9007676)
Owner / Operator Contact Address
250 Campus Drive, --, Marlborough, MA 01752, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K202114
PMA Number
N/A

All Registered Proprietary Names

CoolSeal Mini; CoolSeal Generator

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2025-07-25

Official Correspondent

Sue Dahlquist

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

HOLOGIC, INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3013649990 HEALTH BEACONS, INC. Marlborough, MA, US
3012644426 ENDOMAGNETICS LTD Cambridge Cambridgeshire, GB
3005875675 GYNESONICS, INC. REDWOOD CITY, CA, US
3006330030 Hologic, Inc. Marlborough, MA, US
3014090621 SOMATEX Medical Technologies GmbH Blankenfelde-Mahlow Brandenburg, DE

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K970809 Somnus Medical Technologies, Inc. BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL 1997-06-18
K222793 C.R. Bard, Inc. WavelinQ™ Generator 2022-10-17
K002257 Tecno Instruments (Pvt.) , Ltd. TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100 2000-10-19
K193591 Bowa-Electronics GmbH & Co. KG ARC 400 2020-04-02
K192128 Sutter Medizintechnik GmbH Sutter Arrowtip Monopolar Electrodes 2019-10-04

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0031-06 Rita Medical Systems 2
Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

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3012616488 BRERA MEDICAL INCORPORATED Northborough, MA, US
3012940012 Sutter Medical Technologies USA Inc. Alpharetta, GA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010377594. Last updated year: 2026. Please use registration number 3010377594 when referencing this establishment in official correspondence.
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