Identity
- Trade Name
- EndoWrist Stapler 30 Curved-Tip EUDAMEDEndoWrist FDA UDI
- Generic Name
- Robotic surgical cutting stapler, reusable FDA UDI
- Device Name
- EndoWrist Stapler instrument EUDAMEDCURVED-TIP STAPLER 30 FDA UDI
- Model / Reference
- 470530 EUDAMEDFDA UDI
- Description
- CURVED-TIP STAPLER 30 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00886874112717 EUDAMEDFDA UDI
- Basic UDI-DI
- 08868741209658X EUDAMED
- FDA Product Code
- NAY FDA UDI
- EMDN Code
- H02030199 LINEAR STAPLERS FOR VIDEOSURGERY - OTHER EUDAMED
- GMDN Term
- Robotic surgical cutting stapler, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
Yes
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
Dimensions & Sizes
- Size
- Outer Diameter — 12 Millimeter FDA UDI
Category: Robotic surgical cutting stapler, reusable
EndoWrist by Intuitive Surgical, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Robotic surgical cutting stapler, reusable.
- EndoWrist — Intuitive Surgical, Inc. · Class II
- EndoWrist — Intuitive Surgical, Inc. · Class II
- EndoWrist;daVinci Si — Intuitive Surgical, Inc. · Class II
- EndoWrist — Intuitive Surgical, Inc. · Class II
- Sureform — Intuitive Surgical, Inc. · Class II
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
- Intuitive Surgical, Inc.
Sources (2)
- FDA UDI a5f267f4-2810-47b9-afc6-611adce1e435 34 fields · synced Jul 28, 2026
- EUDAMED c746aa6d-68e3-45ce-ad53-d221fb484332 61 fields · synced Jul 28, 2026