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FocESS

FDA UDI

Class II (US FDA UDI)

by Stryker Corp.

Identity

Trade Name
FocESS FDA UDI
Generic Name
Rigid optical sinoscope FDA UDI
Device Name
Sinuscope, 0 degree FDA UDI
Model / Reference
ES-0 FDA UDI
Description
Sinuscope, 0 degree FDA UDI

Identifiers

Catalog Number
ES-0 FDA UDI
Primary DI / UDI-DI
00857326005598 FDA UDI
510(k) Number
K981751 FDA UDI
FDA Product Code
EOB FDA UDI
GMDN Term
Rigid optical sinoscope 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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Angle — 0 degree FDA UDI
Outer Diameter — 3 Millimeter FDA UDI

Category: Rigid optical sinoscope

FocESS by Stryker Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Rigid optical sinoscope.

Cleared under the same submission

K981751 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Stryker Corp.

Sources (1)

  • FDA UDI a928c914-9f89-4f66-9a34-a6c07f3c00fb 36 fields · synced May 30, 2026