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Sinuscope

FDA UDI

Class II (US FDA UDI)

by PENTAX of America, Inc.

Identity

Trade Name
SINUSCOPE FDA UDI
Generic Name
Rigid optical nasopharyngoscope FDA UDI
Device Name
8853 SINUSCOPE FDA UDI
Model / Reference
8853-R FDA UDI
Description
8853 SINUSCOPE FDA UDI

Identifiers

Primary DI / UDI-DI
04961333231652 FDA UDI
510(k) Number
K944656 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
Not 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
Angle — 0 degree FDA UDI
Outer Diameter — 4.0 Millimeter FDA UDI

Sinuscope by PENTAX of America, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K944656 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
PENTAX of America, Inc.

Sources (1)

  • FDA UDI b0f50191-83fc-4c18-a841-88ccf94577b2 36 fields · synced Jun 8, 2026