Identifiers
- 510(k) Number
- K941333 FDA 510(k)
- FDA Product Code
- HRX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.1100 FDA 510(k)
- Regulation Number
- 888.1100 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The SE5 Arthroscopy System is a medical device designed for use in orthopedic procedures, including arthroscopy of joints such as the knee, shoulder, ankle, elbow, wrist, hip, and temporomandibular joint. It is intended to assist surgeons in visualizing and treating joint conditions through minimally invasive techniques.
The device is supplied as a system that includes an arthroscopy console, shaver handpieces, and a foot switch. It is intended for single-use in clinical settings and must be used in accordance with the manufacturer's instructions. The device is not sterilized and requires proper handling and storage to maintain its integrity.
Frequently asked questions
What is the SE5 Arthroscopy System used for?
The SE5 Arthroscopy System is designed to assist surgeons in visualizing and treating joint conditions through minimally invasive techniques. It is intended for use in arthroscopy procedures on various joints, including the knee, shoulder, ankle, elbow, wrist, hip, and temporomandibular joint.
Is the SE5 Arthroscopy System sterile?
No, the SE5 Arthroscopy System is not sterilized. It must be used in accordance with the manufacturer's instructions and requires proper handling and storage to maintain its integrity.
Is the SE5 Arthroscopy System intended for single use?
Yes, the SE5 Arthroscopy System is intended for single-use in clinical settings. It is supplied as a system that includes an arthroscopy console, shaver handpieces, and a foot switch.
What components are included in the SE5 Arthroscopy System?
The SE5 Arthroscopy System is supplied as a system that includes an arthroscopy console, shaver handpieces, and a foot switch.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Stryker Se5 Arthroscopy System With Hermes Voice Control, Stryker SE-5 Arthroscopic Shaver - Soma Tech Intl, STRYKER SE5 ARTHROSCOPY SYSTEM WITH HERMES VOICE… - FDA.report, SE5 ARTHROSCOPY SYTEM (K941333) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K941333 | Class II | Active |
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Manufacturer
- Manufacturer
- Stryker Endoscopy
Sources (1)
- FDA 510(k) K941333 24 fields · synced Sep 25, 2026