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OptIcSurgN

FDA UDI

Class II (US FDA UDI)

by Smartsurgn Inc.

Identity

Trade Name
OptIcSurgN FDA UDI
Generic Name
Rigid optical laparoscope FDA UDI
Device Name
OptIcRSurgN 10mm ICG Laparoscope 0° FDA UDI
Model / Reference
FG1122 FDA UDI
Description
OptIcRSurgN 10mm ICG Laparoscope 0° FDA UDI

Identifiers

Primary DI / UDI-DI
G465FG11220 FDA UDI
510(k) Number
K213943 FDA UDI
FDA Product Code
OWN FDA UDI
GMDN Term
Rigid optical 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

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 laparoscope

OptIcSurgN by Smartsurgn Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Rigid optical laparoscope.

Cleared under the same submission

K213943 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 2f6e0188-0ecd-46b1-86e8-a55bc2946454 34 fields · synced Jun 6, 2026