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Non-ICG 4mm Sinuscope (0 Deg)

FDA UDI

Class II (US FDA UDI)

by Smartsurgn Inc.

Identity

Trade Name
Non-ICG 4mm Sinuscope (0 Deg) FDA UDI
Generic Name
Rigid optical sinoscope FDA UDI
Device Name
Non-ICG 4mm Sinuscope (0 Deg) FDA UDI
Model / Reference
FG-15 FDA UDI
Description
Non-ICG 4mm Sinuscope (0 Deg) FDA UDI

Identifiers

Primary DI / UDI-DI
G465FG15000 FDA UDI
510(k) Number
K032822 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

Category: Rigid optical sinoscope

Non-ICG 4mm Sinuscope (0 Deg) by Smartsurgn Inc. — 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

K032822 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Smartsurgn Inc.

Sources (1)

  • FDA UDI e61d1f0c-2516-40e2-89a1-25acbb430fc1 34 fields · synced Jun 8, 2026