Identity
- Trade Name
- Saberscope FDA UDI
- Generic Name
- Flexible-tip video laparoscope FDA UDI
- Device Name
- 5 mm Articulating Laparoscope FDA UDI
- Model / Reference
- XSA-0-0536 FDA UDI
- Description
- 5 mm Articulating Laparoscope FDA UDI
Identifiers
- Catalog Number
- XSA-0-0536 FDA UDI
- Primary DI / UDI-DI
- 00854490007038 FDA UDI
- FDA Product Code
- GCJ FDA UDIGCQ FDA UDI
- GMDN Term
- Flexible-tip video laparoscope 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
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Flexible-tip video laparoscope
Saberscope by Xenocor, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible-tip video laparoscope.
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- Ideal Eyes — Stryker Corp. · Class II
Cleared under the same submission
K193315 also covers:
K220872 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
- Xenocor, Inc.
Sources (1)
- FDA UDI 9c920c72-5389-4d61-81f3-2e61b0137699 35 fields · synced May 30, 2026