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Sign in to claim this brandSolos 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
- —
- —
- [email protected]
- Phone
- 781-834-9500
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 625281332
Catalogue (43)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Solos | GS6005 | FDA UDI | Class II | Active |
| Solos | GS5200 | FDA UDI | Class II | Active |
| Solos | GS1000DN | FDA UDI | Class II | Active |
| Solos | GI1065 | FDA UDI | Class II | Active |
| Solos | GS5000 | FDA UDI | Class II | Active |
| Solos | GS1100 | FDA UDI | Class II | Active |
| Solos | GS1305 | FDA UDI | Class II | Active |
| Solos | GI1190 | FDA UDI | Class II | Active |
| Solos | GS1365 | FDA UDI | Class II | Active |
| Solos | GS1000R | FDA UDI | Class II | Active |
| Solos | GS1365R | FDA UDI | Class II | Active |
| Solos | GS1500 | FDA UDI | Class II | Active |
| Solos | GS1305R | FDA UDI | Class II | Active |
| Solos | GI1070 | FDA UDI | Class II | Active |
| Solos | GI1050 | FDA UDI | Class II | Active |
| Solos | GS6000 | FDA UDI | Class II | Active |
| Solos | GI1055 | FDA UDI | Class II | Active |
| Solos | GS1000 | FDA UDI | Class II | Active |
| Solos | GS1002 | FDA UDI | Class II | Active |
| Solos | GS5250 | FDA UDI | Class II | Active |
| Solos | GS1340 | FDA UDI | Class II | Active |
| Solos | GU1540 | FDA UDI | Class II | Active |
| Gs-1000 Grasping Forcep, 5mm, Insulated | K900947 | FDA 510(k) | Class II | Active |
| Gs-5200 Hook Suction/Coagulator, 5mm | K900954 | FDA 510(k) | Class II | Active |
| Gs-5000 Spatula Suction/Coagulator, 5mm | K900953 | FDA 510(k) | Class II | Active |
| Gs-4550 Trocar Only, 11mm | K900965 | FDA 510(k) | Class I | Active |
| Model Gs-4700 Common Duct Stone Removing Kit | K910671 | FDA 510(k) | Class II | Active |
| Gs-4100 Reducer Sleeve, 5mm To 3mm | K900961 | FDA 510(k) | Class I | Active |
| Gs-2000 Micro Scissor, Curved Left, 5mm | K900950 | FDA 510(k) | Class I | Active |
| Gs-1002 Grasping Forcep, 5mm With Ratchet | K900948 | FDA 510(k) | Class I | Active |
| Gs-7000 Clip-Applying Forcep, 10mm, Medium Clip | K900951 | FDA 510(k) | Class I | Active |
| Gs-1100 Micro Dissecting Forcep, 5mm, Insulated | K900949 | FDA 510(k) | Class II | Active |
| Gs-4350 Trocar Only, 5.5mm | K900963 | FDA 510(k) | Class I | Active |
| Gs-4300 Cannula And Trocar, 5.5mm | K900962 | FDA 510(k) | Class I | Active |
| Miniaturized Biopsy, Scope A.k.a: Biopsy Needle With Endoscopic Viewing Capability | K983538 | FDA 510(k) | Class II | Active |
| Gs-7100 Cholangiogram Clamp, 5mm | K900956 | FDA 510(k) | Class I | Active |
| Gs-1300 Atraumatic Grasping Forcep, Curved, 10mm | K900958 | FDA 510(k) | Class I | Active |
| Gs-4000 Reducer Sleeve, 11mm To 5mm | K900955 | FDA 510(k) | Class I | Active |
| Gs-2100 Hook Suture Scissor, 5mm | K900957 | FDA 510(k) | Class I | Active |
| Gs-1500 Claw Forcep, 10mm | K900960 | FDA 510(k) | Class I | Active |
| Gs-1400 Toothed Dissecting Forcep, 5mm, Insulated | K900959 | FDA 510(k) | Class I | Active |
| Cannula And Trocar, 11mm | K900964 | FDA 510(k) | Class I | Active |
| Gs-1200 Grasping/Extracting Forcep, 10mm | K900952 | FDA 510(k) | Class I | Active |
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