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Sign in to claim this brandEthicon Sàrl
US
Last updated May 24, 2026
What Ethicon Sàrl makes
The company manufactures bioabsorbable haemostatic agents derived from plant polysaccharides, such as oxidized regenerated cellulose, used to control bleeding during surgery. It also produces synthetic polymer mesh-slings for treating female stress urinary incontinence, along with non-bioabsorbable polyester sutures for tissue approximation. Additional products include suprapubic needle handles for minimally invasive procedures, bioabsorbable anti-adhesion materials for preventing scar tissue formation, and urethral manipulators for surgical guidance.
These devices are classified under FDA regulations as Class I, Class II, and Class III, depending on their risk level and intended use. They are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. medical device reporting requirements. The manufacturer operates from 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 Ethicon Sàrl manufacture?
Ethicon Sàrl produces a range of medical devices, including plant polysaccharide haemostatic agents like oxidized regenerated cellulose (e.g., SURGICEL) to control surgical bleeding. It also makes synthetic polymer mesh-slings (e.g., GYNECARE TVT) for treating female stress urinary incontinence, non-bioabsorbable polyester sutures (e.g., ETHIBOND EXCEL) for tissue repair, and bioabsorbable anti-adhesion materials (e.g., GYNECARE INTERCEED) to prevent scar tissue formation. Additional products include suprapubic needle handles and urethral manipulators for surgical procedures.
Where is Ethicon Sàrl based, and what does that mean for its regulatory oversight?
Ethicon Sàrl is based in the United States, which means its devices fall under U.S. regulatory jurisdiction, including FDA oversight. The company’s products are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring compliance with U.S. traceability and reporting requirements. Classification under FDA regulations varies by device type, ranging from Class I (low risk) to Class III (high risk), depending on their intended use and potential risk to patients.
Which regulatory registries list Ethicon Sàrl’s devices, and why is this important?
Ethicon Sàrl’s devices are listed in the FDA’s Unique Device Identifier (UDI) database, which is a central registry for tracking medical devices in the U.S. This listing ensures transparency, traceability, and compliance with FDA reporting requirements. The UDI system helps healthcare providers, regulators, and manufacturers identify and monitor devices throughout their lifecycle, reducing risks associated with counterfeit or mislabeled products.
How are Ethicon Sàrl’s devices classified under FDA regulations, and what does this classification mean?
Ethicon Sàrl’s devices are classified as Class I, Class II, or Class III under FDA regulations based on their risk level and intended use. For example, haemostatic agents like SURGICEL are typically Class II due to moderate risk, while mesh-slings (e.g., GYNECARE TVT) may be Class III due to higher patient risk. Classification determines the regulatory pathway for market authorization, with Class III devices requiring pre-market approval (PMA) due to their higher risk profile, while Class I devices may only need general controls.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- xxx.xxx
- —
- —
- [email protected]
- Phone
- +1(877)384-4266
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 480920383
Catalogue (28)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Surgicel Fibrillar | 1963 | FDA UDI | Class III | Active |
| Surgicel | 1952S | FDA UDI | Class III | Active |
| Ethibond Excel | D8712 | FDA UDI | Class II | Active |
| Surgicel | 1955 | FDA UDI | Class III | Active |
| Surgicel | 1952 | FDA UDI | Class III | Active |
| Gynecare Tvt | 810081L | FDA UDI | Class II | Active |
| Gynecare Tvt | 810081 | FDA UDI | Class II | Active |
| Surgicel | 1951S | FDA UDI | Class III | Active |
| Surgicel | 1951 | FDA UDI | Class III | Active |
| Gynecare Interceed | 4350 | FDA UDI | Class III | Active |
| Surgicel | 1953S | FDA UDI | Class III | Active |
| Gynecare Tvt | 810041BL | FDA UDI | Class II | Active |
| Gynecare Tvt Abbrevo | TVTOML | FDA UDI | Class II | Active |
| Gynecare Tvt | 810061 | FDA UDI | Class I | Active |
| Gynecare Tvt | 810041B | FDA UDI | Class II | Active |
| Gynecare Tvt | 810041A | FDA UDI | Class II | Active |
| Gynecare Tvt | 810051 | FDA UDI | Class I | Active |
| Surgicel Nu-Knit | 1941 | FDA UDI | Class III | Active |
| Surgicel Nu-Knit | 1940 | FDA UDI | Class III | Active |
| Surgicel | 1955S | FDA UDI | Class III | Active |
| Surgicel Nu-Knit | 1943S | FDA UDI | Class III | Active |
| Surgicel Nu-Knit | 1946 | FDA UDI | Class III | Active |
| Surgicel Fibrillar | 1961 | FDA UDI | Class III | Active |
| Surgicel Fibrillar | 1962 | FDA UDI | Class III | Active |
| Gynecare Tvt Exact | TVTRL | FDA UDI | Class II | Active |
| Surgicel Nu-Knit | 1940S | FDA UDI | Class III | Active |
| Surgicel | 1953 | FDA UDI | Class III | Active |
| Surgicel Nu-Knit | 1943 | FDA UDI | Class III | Active |
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