Identity
- Trade Name
- Endosuture System Endo-Holder EUDAMEDETHICON FDA UDI
- Generic Name
- Suture/ligature tightener, reusable FDA UDI
- Device Name
- Endosuture System Endo-Holder EUDAMEDCannula Reusable Knot Pusher FDA UDI
- Model / Reference
- ESS15 EUDAMEDFDA UDI
- Description
- Cannula Reusable Knot Pusher FDA UDI
Identifiers
- Catalog Number
- ESS15 FDA UDI
- Primary DI / UDI-DI
- 10705031148161 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705031a000013K EUDAMED
- 510(k) Number
- K963329 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- EMDN Code
- L0299 SUTURE INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Suture/ligature tightener, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Suture/ligature tightener, reusable
Ethicon by Ethicon Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ethicon Inc.
Sources (2)
- FDA UDI 2bf5893e-e516-4af2-9bd1-58d09965846e 36 fields · synced Jul 15, 2026
- EUDAMED ab4d6379-3441-4bc7-8917-55540e1d30f3 61 fields · synced Jul 15, 2026