Saneso

FDA UDI

Class II (US FDA UDI)

by Saneso, Inc.

Identity

Trade Name: Saneso FDA UDI
Generic Name: Flexible video gastroscope, reusable FDA UDI
Device Name: Saneso Single Camera Gastroscope with high definition imaging, 140-160 degree FOV, lens wash system, dedicated tissue wash system, LED lighting, select band imaging, a vertical & horizontal bending radius of 180 & 160 degrees. FDA UDI
Model / Reference: SAN1G-A FDA UDI
Description: Saneso Single Camera Gastroscope with high definition imaging, 140-160 degree FOV, lens wash system, dedicated tissue wash system, LED lighting, select band imaging, a vertical & horizontal bending radius of 180 & 160 degrees. FDA UDI

Identifiers

Primary DI / UDI-DI: G347SAN1GA0 FDA UDI
510(k) Number: K210052 FDA UDI
FDA Product Code: FDS FDA UDI
GMDN Term: Flexible video gastroscope, reusable 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Length — 1040 Millimeter FDA UDI
Outer Diameter — 11.6 Millimeter FDA UDI

Category: Flexible video gastroscope, reusable

Saneso by Saneso, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Flexible video gastroscope, reusable.

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VIDEO GASTROSCOPE — PENTAX of America, Inc. · Class II
PENTAX Medical — HOYA CORPORATION · Class II
PENTAX — HOYA CORPORATION · Class II
VIDEO GASTROSCOPE — PENTAX of America, Inc. · Class II
PENTAX — HOYA CORPORATION · Class II
VIDEO SIGMOIDOSCOPE — PENTAX of America, Inc. · Class II

Cleared under the same submission

K210052 also covers:

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

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Manufacturer

Manufacturer: Saneso, Inc.

Sources (1)

FDA UDI 3f1aa0f0-bdf6-4485-b744-041d7b79795b 36 fields · synced May 30, 2026