Identity
- Trade Name
- Sharpsite® FDA UDI
- Generic Name
- Rigid optical nasopharyngoscope FDA UDI
- Device Name
- ENDOSCOPE 1880160X SHARPSITE X 2.7MM/0DG FDA UDI
- Model / Reference
- 1880160X FDA UDI
- Description
- ENDOSCOPE 1880160X SHARPSITE X 2.7MM/0DG FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00643169937468 FDA UDI
- 510(k) Number
- K965233 FDA UDI
- FDA Product Code
- EOB FDA UDI
- GMDN Term
- Rigid optical nasopharyngoscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4760 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 UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 2.7 Millimeter FDA UDIAngle — 0.0 degree FDA UDI
Category: Rigid optical nasopharyngoscope
Sharpsite® by Medtronic Xomed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rigid optical nasopharyngoscope.
- RIGID SCOPES — PENTAX of America, Inc. · Class I
- RIGID SCOPES — PENTAX of America, Inc. · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
- ACCLARENT CYCLOPS — ACCLARENT, INC. · Class II
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
- SINUSCOPE — PENTAX of America, Inc. · Class II
- SINUSCOPE — PENTAX of America, Inc. · Class II
- SINUSCOPE — PENTAX of America, Inc. · Class II
Cleared under the same submission
K965233 also covers:
- SHARPSITE® — MEDTRONIC XOMED, INC.
- SHARPSITE® — MEDTRONIC XOMED, INC.
- SHARPSITE® — MEDTRONIC XOMED, INC.
- SHARPSITE® — MEDTRONIC XOMED, INC.
- SHARPSITE® — MEDTRONIC XOMED, INC.
- SHARPSITE® — MEDTRONIC XOMED, INC.
- Sharpsite® — MEDTRONIC XOMED, INC.
- Sharpsite® — MEDTRONIC XOMED, INC.
- Sharpsite® — MEDTRONIC XOMED, INC.
- Sharpsite® — MEDTRONIC XOMED, INC.
- Sharpsite® — MEDTRONIC XOMED, INC.
- Sharpsite® — MEDTRONIC XOMED, 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
- Medtronic Xomed, Inc.
Sources (1)
- FDA UDI 3b135b4b-5960-4892-8033-b440bba7fc44 36 fields · synced May 30, 2026