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Sign in to claim this brandConkin Surgical Instruments , Ltd.
US
Last updated May 30, 2026
What Conkin Surgical Instruments , Ltd. makes
Conkin Surgical Instruments, Ltd. manufactures reusable surgical instrument trays and single-use ophthalmic angular gauges, including the Tor-Mark Ocular Marker. Their primary product is the Valtchev Uterine Mobilizer, a uterine elevator designed for gynecological procedures.
The company’s devices are regulated under FDA classifications, with most falling into Class I and Class II categories. These products are listed in the FDA’s 510(k) and UDI registries, reflecting their compliance with U.S. medical device authorization requirements. 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 Conkin Surgical Instruments, Ltd. manufacture?
Conkin Surgical Instruments, Ltd. specializes in reusable surgical instrument trays and single-use ophthalmic angular gauges. Their most prominent product is the Valtchev Uterine Mobilizer, a uterine elevator used in gynecological surgeries. This device falls under the broader category of surgical instruments designed for specific procedural needs.
Where is Conkin Surgical Instruments, Ltd. based?
The company is headquartered in the United States. This location influences its regulatory compliance, particularly with U.S. medical device authorization frameworks like the FDA’s requirements.
Which regulatory registries list Conkin Surgical Instruments, Ltd.’s devices?
Conkin Surgical Instruments, Ltd.’s devices are listed in the FDA’s 510(k) and UDI (Unique Device Identification) registries. These registries ensure traceability and compliance with U.S. medical device authorization processes, helping track devices through manufacturing, distribution, and use.
How are Conkin Surgical Instruments, Ltd.’s devices classified under FDA regulations?
The company’s devices are primarily classified as Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use and potential risks.
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
- 257261032
Catalogue (13)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Valtchev Uterine Mobilizer | 8 | FDA UDI | Class II | Active |
| Valtchev Uterine Mobilizer | 20 | FDA UDI | Class II | Active |
| Valtchev Uterine Mobilizer | VUM-6 | FDA UDI | Class II | Active |
| Tray, Surgical Instrument | ST-6 | FDA UDI | Class I | Active |
| Valtchev Uterine Mobilizer | 16A | FDA UDI | Class II | Active |
| Valtchev Uterine Mobilizer | 19 | FDA UDI | Class II | Active |
| Valtchev Uterine Mobilizer | 18 | FDA UDI | Class II | Active |
| Valtchev Uterine Mobilizer | 17 | FDA UDI | Class II | Active |
| Valtchev Uterine Mobilizer | 15A | FDA UDI | Class II | Active |
| Valtchev Uterine Mobilizer | 9A | FDA UDI | Class II | Active |
| Valtchev Uterine Mobilizer | VT | FDA UDI | Class II | Active |
| Tor-Mark Ocular Marker | Tor-Mark-10 | FDA UDI | Class I | Active |
| Single Channel Balloon Cannula | K974801 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Conkin Surgical Instruments Ltd. Vancouver British Columbia · CA FEI 3006049570