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Solos Endoscopy, Inc.

US

Last updated May 30, 2026

What Solos Endoscopy, Inc. makes

Solos Endoscopy, Inc. manufactures reusable rigid endoscopic tissue manipulation forceps, designed for precise tissue handling during endoscopic procedures. They also produce electrical-only connection cables for medical devices, available in both reusable and single-use variants, ensuring compatibility with endoscopic systems.

The company’s products are regulated under FDA classifications, including Class I and Class II devices, with authorisation pathways such as the 510(k) and Unique Device Identification (UDI) requirements. These devices are listed in the FDA’s regulatory databases and are intended for use in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Solos Endoscopy, Inc. manufacture?

Solos Endoscopy, Inc. specializes in reusable rigid endoscopic tissue manipulation forceps, which are used for precise tissue handling during endoscopic procedures. Additionally, they produce electrical-only connection cables for medical devices, available in both reusable and single-use forms. These cables are designed to ensure compatibility with endoscopic systems, supporting safe and reliable electrical connectivity.

Where is Solos Endoscopy, Inc. based, and what regulatory databases list its devices?

Solos Endoscopy, Inc. is based in the United States. Their devices are listed in the FDA’s regulatory databases, specifically under the 510(k) premarket notification pathway and the Unique Device Identification (UDI) program. These listings reflect the company’s compliance with U.S. regulatory requirements for medical devices.

How are the devices manufactured by Solos Endoscopy, Inc. classified under FDA regulations?

The devices produced by Solos Endoscopy, Inc. fall under FDA classifications of Class I and Class II. Class I devices are generally considered low-risk and may require less stringent regulatory controls, while Class II devices involve moderate risk and typically require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway and requirements for authorisation.

Are the devices from Solos Endoscopy, Inc. available in reusable and single-use options?

Yes, Solos Endoscopy, Inc. offers both reusable and single-use variants of their electrical-only medical device connection cables. The reusable forceps are designed for repeated use in clinical settings, while the single-use cables provide a sterile option for procedures where contamination risk is a concern. This variety allows healthcare providers to choose based on their specific clinical needs and operational preferences.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Address
—
Website
ksp.com
LinkedIn
—
Facebook
—
Phone
781-834-9500
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
625281332

Catalogue (43)

DeviceModel / ReferenceRegistriesClassStatus
Solos GS6005
FDA UDI
Class IIActive
Solos GS5200
FDA UDI
Class IIActive
Solos GS1000DN
FDA UDI
Class IIActive
Solos GI1065
FDA UDI
Class IIActive
Solos GS5000
FDA UDI
Class IIActive
Solos GS1100
FDA UDI
Class IIActive
Solos GS1305
FDA UDI
Class IIActive
Solos GI1190
FDA UDI
Class IIActive
Solos GS1365
FDA UDI
Class IIActive
Solos GS1000R
FDA UDI
Class IIActive
Solos GS1365R
FDA UDI
Class IIActive
Solos GS1500
FDA UDI
Class IIActive
Solos GS1305R
FDA UDI
Class IIActive
Solos GI1070
FDA UDI
Class IIActive
Solos GI1050
FDA UDI
Class IIActive
Solos GS6000
FDA UDI
Class IIActive
Solos GI1055
FDA UDI
Class IIActive
Solos GS1000
FDA UDI
Class IIActive
Solos GS1002
FDA UDI
Class IIActive
Solos GS5250
FDA UDI
Class IIActive
Solos GS1340
FDA UDI
Class IIActive
Solos GU1540
FDA UDI
Class IIActive
Gs-1000 Grasping Forcep, 5mm, Insulated K900947
FDA 510(k)
Class IIActive
Gs-5200 Hook Suction/Coagulator, 5mm K900954
FDA 510(k)
Class IIActive
Gs-5000 Spatula Suction/Coagulator, 5mm K900953
FDA 510(k)
Class IIActive
Gs-4550 Trocar Only, 11mm K900965
FDA 510(k)
Class IActive
Model Gs-4700 Common Duct Stone Removing Kit K910671
FDA 510(k)
Class IIActive
Gs-4100 Reducer Sleeve, 5mm To 3mm K900961
FDA 510(k)
Class IActive
Gs-2000 Micro Scissor, Curved Left, 5mm K900950
FDA 510(k)
Class IActive
Gs-1002 Grasping Forcep, 5mm With Ratchet K900948
FDA 510(k)
Class IActive
Gs-7000 Clip-Applying Forcep, 10mm, Medium Clip K900951
FDA 510(k)
Class IActive
Gs-1100 Micro Dissecting Forcep, 5mm, Insulated K900949
FDA 510(k)
Class IIActive
Gs-4350 Trocar Only, 5.5mm K900963
FDA 510(k)
Class IActive
Gs-4300 Cannula And Trocar, 5.5mm K900962
FDA 510(k)
Class IActive
Miniaturized Biopsy, Scope A.k.a: Biopsy Needle With Endoscopic Viewing Capability K983538
FDA 510(k)
Class IIActive
Gs-7100 Cholangiogram Clamp, 5mm K900956
FDA 510(k)
Class IActive
Gs-1300 Atraumatic Grasping Forcep, Curved, 10mm K900958
FDA 510(k)
Class IActive
Gs-4000 Reducer Sleeve, 11mm To 5mm K900955
FDA 510(k)
Class IActive
Gs-2100 Hook Suture Scissor, 5mm K900957
FDA 510(k)
Class IActive
Gs-1500 Claw Forcep, 10mm K900960
FDA 510(k)
Class IActive
Gs-1400 Toothed Dissecting Forcep, 5mm, Insulated K900959
FDA 510(k)
Class IActive
Cannula And Trocar, 11mm K900964
FDA 510(k)
Class IActive
Gs-1200 Grasping/Extracting Forcep, 10mm K900952
FDA 510(k)
Class IActive

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