Identity
- Trade Name
- VersaOne FDA UDI
- Generic Name
- Suturing unit, reusable FDA UDI
- Device Name
- Fascial Closure System Reusable Suture Passer FDA UDI
- Model / Reference
- FCSPASS FDA UDI
- Description
- Fascial Closure System Reusable Suture Passer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10884521678705 FDA UDI30884521678709 FDA UDI
- 510(k) Number
- K163654 FDA UDI
- FDA Product Code
- GCJ FDA UDI
- GMDN Term
- Suturing unit, 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
No
FDA UDIFDA UDI
Serial Number
Yes
FDA UDIFDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDIFDA UDI
Ethylene Oxide FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Suturing unit, reusable
VersaOne by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Suturing unit, reusable.
- Hip Suture Grasper — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION · Class I
- Arthrex® — Arthrex, Inc. · Class I
- Arthrex® — Arthrex, Inc. · Class I
- Suture Manipulator Grasper — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION · Class I
- Knot Manipulator Full Loop — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION · Class I
- Arthrex® — Arthrex, Inc. · Class I
- Arthrex® — Arthrex, Inc. · Class I
- HAT-TRICK — Smith & Nephew, Inc. · Class I
Cleared under the same submission
K163654 also covers:
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 |
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Manufacturer
- Manufacturer
- Covidien LP
Sources (2)
- FDA UDI 79b5f8cd-18b3-4e26-ba2b-92df67882648 35 fields · synced Jun 8, 2026
- FDA UDI dd790b1b-70ba-4f7d-ae40-556029dee6a1 36 fields · synced May 26, 2026