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Sign in to claim this brandWhat SURGICAL INNOVATIONS LIMITED makes
Surgical Innovations Limited manufactures reusable laparoscopic instruments, including medical table clamps, monopolar electrosurgical electrodes for endoscopic procedures, reusable laparoscopic access cannulas, and laparoscopic blunt dissectors. Their product line includes systems like the Logic Laparoscopic Instrument System and the YelloPort Elite Laparoscopic Port Access System, designed for minimally invasive surgical applications.
The company’s devices are classified under FDA Class II and are authorised through the 510(k) and UDI pathways. These products are listed in the FDA’s regulatory databases, and the manufacturer is based 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 Surgical Innovations Limited manufacture?
Surgical Innovations Limited specialises in reusable laparoscopic instruments. Their product line includes medical table clamps for securing surgical equipment, monopolar electrosurgical electrodes for endoscopic procedures, reusable laparoscopic access cannulas (such as the YelloPort Elite system), and laparoscopic blunt dissectors. These devices are designed for minimally invasive surgeries, enabling precision and efficiency in procedures like laparoscopy.
Where is Surgical Innovations Limited based?
The company is headquartered in the United States. This location is relevant for regulatory compliance, as their devices are authorised under U.S. FDA pathways, including the 510(k) premarket notification process and UDI (Unique Device Identification) requirements.
Which regulatory registries list Surgical Innovations Limited’s devices?
The company’s devices are listed in the FDA’s regulatory databases, specifically under the 510(k) premarket submissions and the UDI (Unique Device Identification) system. These registries ensure transparency and traceability of their Class II medical devices, which undergo evaluation through these pathways before authorisation.
How are Surgical Innovations Limited’s devices classified under FDA regulations?
All of Surgical Innovations Limited’s devices fall under FDA Class II classification. This classification indicates moderate risk, requiring pre-market notification (510(k)) to demonstrate substantial equivalence to a legally marketed predicate device. The company’s products, such as the Fastclamp or Logic Laparoscopic Instrument System, must meet specific performance and safety criteria before being authorised.
Why are Surgical Innovations Limited’s devices authorised through the 510(k) and UDI pathways?
The 510(k) pathway is used for Class II devices to demonstrate that a new device is substantially equivalent to an existing, legally marketed device in terms of safety and effectiveness. The UDI system ensures unique identification of devices throughout their lifecycle, improving tracking, traceability, and post-market surveillance. These pathways are standard for reusable laparoscopic instruments like those from Surgical Innovations Limited, ensuring compliance with U.S. regulatory requirements.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 771051935
Catalogue (97)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| YelloPort Plus | YC1615020 | FDA UDI | Class II | Unknown |
| YelloPort Plus - Laparoscopic Port Access System | YA010STS | FDA UDI | Class II | Unknown |
| YelloPort | 550004S | FDA UDI | Class II | Unknown |
| YelloPort | 530004S | FDA UDI | Class II | Unknown |
| YelloPort Plus | YC1615020 | FDA UDI | Class II | Unknown |
| YelloPort Plus - Laparoscopic Port Access System | YC0509532 | FDA UDI | Class II | Unknown |
| YelloPort Plus | YOH1201 | FDA UDI | Class II | Unknown |
| YelloPort Plus - Laparoscopic Port Access System | YC0509530 | FDA UDI | Class II | Unknown |
| YelloPort Plus | YC1010521 | FDA UDI | Class II | Unknown |
| YelloPort Plus - Laparoscopic Port Access System | YC0505532 | FDA UDI | Class II | Unknown |
| YelloPort Plus - Laparoscopic Port Access System | YT1210506 | FDA UDI | Class II | Unknown |
| YelloPort.tif | Stopcock Tap Assembly | FDA UDI | Class II | Unknown |
| YelloPort Plus - Laparoscopic Port Access System | YT1015007 | FDA UDI | Class II | Unknown |
| YelloPort Plus - Laparoscopic Port Access System | YT1015004 | FDA UDI | Class II | Unknown |
| YelloPort Plus - Laparoscopic Port Access System | YT1215003 | FDA UDI | Class II | Unknown |
| YelloPort Plus - Laparoscopic Port Access System | YA10HS05 | FDA UDI | Class II | Unknown |
| YelloPort Plus | YA10105LT | FDA UDI | Class II | Unknown |
| YelloPort Plus | YOI1210510 | FDA UDI | Class II | Unknown |
| YelloPort Plus | YC1215021 | FDA UDI | Class II | Unknown |
| Logi - Laparoscopic Instrument System | 120-7013 | FDA UDI | Class II | Unknown |
| YelloPort Plus | YOI1210503 | FDA UDI | Class II | Unknown |
| YelloPort Plus - Laparoscopic Port Access System | YC0505530 | FDA UDI | Class II | Unknown |
| YelloPort Plus - Laparoscopic Port Access System | YC1215022 | FDA UDI | Class II | Unknown |
| YelloPort Plus - Laparoscopic Port Access System | YA05CC01 | FDA UDI | Class II | Unknown |
| YelloPort Plus - Laparoscopic Port Access System | YA12SH | FDA UDI | Class II | Unknown |
| YelloPort Plus.tif | YA05070SP | FDA UDI | Class II | Unknown |
| YelloPort Plus | YOH1201 | FDA UDI | Class II | Unknown |
| Logi | 459-7000 | FDA UDI | Class II | Unknown |
| YelloPort Plus - Laparoscopic Port Access System | YT1015009 | FDA UDI | Class II | Unknown |
| Logic | 459-43000 | FDA UDI | Class II | Unknown |
| YelloPort Plus - Laparoscopic Port Access System | YT1210503 | FDA UDI | Class II | Unknown |
| YelloPort Plus | YA05STK10 | FDA UDI | Class II | Unknown |
| YelloPort Plus - Laparoscopic Port Access System | YC0507032 | FDA UDI | Class II | Unknown |
| YelloPort Plus - Laparoscopic Port Access System | YC1010522 | FDA UDI | Class II | Unknown |
| YelloPort Plus - Laparoscopic Port Access System | YT1010506 | FDA UDI | Class II | Unknown |
| YelloPort Plus - Laparoscopic Port Access System | YT1210504 | FDA UDI | Class II | Unknown |
| Fastclamp | A-1000-GSP | FDA UDI | Class II | Active |
| Logic - Laparoscopic Instrument System | 101-47045 | FDA UDI | Class II | Active |
| Fastclamp | IC-1000-02 | FDA UDI | Class II | Active |
| YelloPort Plus - Laparoscopic Port Access System | YT1015003 | FDA UDI | Class II | Unknown |
| Logi - Laparoscopic Instrument System | 120-7014 | FDA UDI | Class II | Unknown |
| YelloPort Plus - Laparoscopic Port Access System | YT1210507 | FDA UDI | Class II | Unknown |
| Fastclamp | BC-1050-02 | FDA UDI | Class II | Active |
| YelloPort Plus - Laparoscopic Port Access System | YT1010507 | FDA UDI | Class II | Unknown |
| YelloPort Plus - Laparoscopic Port Access System | YA10SH | FDA UDI | Class II | Unknown |
| Logi | 459-7002 | FDA UDI | Class II | Unknown |
| YelloPort Plus - Laparoscopic Port Access System | YT1010509 | FDA UDI | Class II | Unknown |
| YelloPort Plus | YA516STS | FDA UDI | Class II | Unknown |
| YelloPort Plus - Laparoscopic Port Access System | YC0507030 | FDA UDI | Class II | Unknown |
| Fastclamp | BC-1090-02 | FDA UDI | Class II | Unknown |
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