Identity
- Trade Name
- arcad® 2.0 FDA UDI
- Generic Name
- Surgical staple loading unit, non-cutting FDA UDI
- Device Name
- Compressive staple Quadro 26x18 FDA UDI
- Model / Reference
- CSK261818 FDA UDI
- Description
- Compressive staple Quadro 26x18 FDA UDI
Identifiers
- Catalog Number
- CSK261818 FDA UDI
- Primary DI / UDI-DI
- 03700879516530 FDA UDI
- 510(k) Number
- K230724 FDA UDI
- FDA Product Code
- JDR FDA UDI
- GMDN Term
- Surgical staple loading unit, non-cutting FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical staple loading unit, non-cutting
arcad® 2.0 by Novastep — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical staple loading unit, non-cutting.
- Endowrist — Intuitive Surgical, Inc. · Class II
- SureForm — Intuitive Surgical, Inc. · Class II
- EndoWrist — Intuitive Surgical, Inc. · Class II
- GIA — Covidien LP · Class II
- EndoWrist — Intuitive Surgical, Inc. · Class II
- SureForm — Intuitive Surgical, Inc. · Class II
- Tri-Staple 2.0 — Covidien LP · Class II
- Endowrist — Intuitive Surgical, Inc. · Class II
Cleared under the same submission
K230724 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
- Novastep
Sources (1)
- FDA UDI ab83ee1d-ae46-45b1-a99d-9d19239efd90 36 fields · synced Jun 8, 2026