Identity
- Trade Name
- EndoWrist SP FDA UDI
- Generic Name
- Robotic surgical needle holder, reusable FDA UDI
- Device Name
- NEEDLE DRIVER FDA UDI
- Model / Reference
- 430200 FDA UDI
- Description
- NEEDLE DRIVER FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00886874123478 FDA UDI
- 510(k) Number
- K241814 FDA UDI
- FDA Product Code
- NAY FDA UDI
- GMDN Term
- Robotic surgical needle holder, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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 — 6 Millimeter FDA UDI
Category: Robotic surgical needle holder, reusable
EndoWrist SP by Intuitive Surgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Robotic surgical needle holder, reusable.
- EndoWrist SP — Intuitive Surgical, Inc. · Class II
- EndoWrist — Intuitive Surgical, Inc. · Class II
- EndoWrist — Intuitive Surgical, Inc. · Class II
- EndoWrist;daVinci Si — Intuitive Surgical, Inc. · Class II
- EndoWrist;daVinci Si — Intuitive Surgical, Inc. · Class II
- Force Feedback — Intuitive Surgical, Inc. · Class II
- Force Feedback — Intuitive Surgical, Inc. · Class II
- Force Feedback — Intuitive Surgical, Inc. · Class II
Cleared under the same submission
K241814 also covers:
- EndoWrist SP — Intuitive Surgical, Inc.
- EndoWrist SP — Intuitive Surgical, Inc.
- EndoWrist SP — Intuitive Surgical, Inc.
- EndoWrist SP — Intuitive Surgical, Inc.
- EndoWrist SP — Intuitive Surgical, Inc.
- EndoWrist SP — Intuitive Surgical, Inc.
- EndoWrist SP — Intuitive Surgical, Inc.
- EndoWrist SP — Intuitive Surgical, Inc.
- EndoWrist SP — Intuitive Surgical, Inc.
- EndoWrist SP — Intuitive Surgical, Inc.
- EndoWrist SP — Intuitive Surgical, Inc.
- EndoWrist SP — Intuitive Surgical, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Intuitive Surgical, Inc.
Sources (1)
- FDA UDI b9d51468-66ba-4772-ac8a-a9a6c4fc14f9 35 fields · synced Jun 9, 2026