Senhance
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Fundus Grasper, Long Ø 5 mm x 410 mm EUDAMEDSenhance FDA UDI
- Generic Name
- Robotic surgical forceps, reusable FDA UDI
- Device Name
- Fundus Grasper, Long FDA UDI
- Model / Reference
- X0007039 EUDAMEDFDA UDISenhance Surgical Instruments EUDAMED
- Description
- Fundus Grasper, Long FDA UDI
Identifiers
- Catalog Number
- 200-11066 FDA UDI
- Primary DI / UDI-DI
- 00815440020255 EUDAMEDFDA UDI
- Basic UDI-DI
- 081544002TD005UM EUDAMED
- Direct Marketing DI
- 00815440020255 EUDAMED
- 510(k) Number
- K171120 FDA UDI
- FDA Product Code
- NAY FDA UDI
- EMDN Code
- L1399 ROBOTIC SURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Robotic surgical forceps, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Length — 410 Millimeter FDA UDIOuter Diameter — 5 Millimeter FDA UDI
Category: Robotic surgical forceps, reusable
Senhance by Asensus Surgical, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Robotic surgical forceps, reusable.
- EndoWrist — Intuitive Surgical, Inc. · Class II
- Kocher Grasper Ø 5 mm x 310 mm — Asensus Surgical Italia S.r.l. · Class IIa
- Fundus Grasper Ø 5 mm x 240 mm — Asensus Surgical Italia S.r.l. · Class IIa
- Toumai — Shanghai MicroPort MedBot (Group) Co., Ltd. · Class I
- Right Angle Dissector, Long Ø 10 mm x length 410 mm — Asensus Surgical Italia S.r.l. · Class IIa
- EndoWrist — Intuitive Surgical, Inc. · Class II
- Single-Site — Intuitive Surgical, Inc. · Class II
- Monopolar L-Hook Electrode Ø 5 mm x 410 mm — Asensus Surgical Italia S.r.l. · Class IIa
Cleared under the same submission
K171120 also covers:
- Senhance — Asensus Surgical, Inc.
- Senhance — Asensus Surgical, Inc.
- Senhance — Asensus Surgical, Inc.
- Senhance — Asensus Surgical, Inc.
- Senhance — Asensus Surgical, Inc.
- Senhance — Asensus Surgical, Inc.
- Senhance — Asensus Surgical, Inc.
- Senhance — Asensus Surgical, Inc.
- Senhance — Asensus Surgical, Inc.
- Senhance — Asensus Surgical, Inc.
- Senhance — Asensus Surgical, Inc.
- Senhance — Asensus Surgical, Inc.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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
- Asensus Surgical, Inc.
Sources (2)
- FDA UDI 3c8fbf83-f05c-47fb-acf2-7dcde44b3dec 36 fields · synced Sep 18, 2026
- EUDAMED 9b717b48-0efa-4586-b9a6-19ef146201e2 61 fields · synced Jul 19, 2026