Saneso SAN1G-A
by Saneso, Inc.
Saneso SAN1G-A is a flexible video gastroscope (FDA Class II; FDA product code FDS, Gastroscope And Accessories, Flexible/Rigid) made by Saneso, Inc., cleared under FDA 510(k) K210052 on 1 Apr 2022 and listed in FDA GUDID since 11 Nov 2022 (UDI-DI G347SAN1GA0), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberG347SAN1GA0 | Date11 Nov 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK210052 | Date1 Apr 2022 | StatusActive |
Official records
- FDA 510(k) database K210052
Across registries
- FDA 510(k) K210052 decided 1 Apr 2022 Active
- FDA GUDID UDI-DI G347SAN1GA0 listed 11 Nov 2022 Listed
Timeline
- Cleared FDA 510(k) K210052
- Listed FDA GUDID G347SAN1GA0
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Saneso
- Generic name
- Flexible video gastroscope, reusable
- Model / reference
- SAN1G-A
- Primary DI / UDI-DI
- G347SAN1GA0
- 510(k) Number
- FDA product code
- FDS
- GMDN term
- Flexible video gastroscope, reusable
- Device class
- Class II
- Regulation number
- 876.1500
- GUDID distribution status
- In Commercial Distribution
- Size
- Length — 1040 MillimeterOuter Diameter — 11.6 Millimeter
Similar devices
Other devices filed under FDA product code FDS (Gastroscope And Accessories, Flexible/Rigid).
- Olympus XGIF-N200H Gastrointestinal Videoscope by Olympus Optical Co., Ltd.
- GripTract-GI Endoscopic Tissue Manipulator Upper GI Model GT-GS100 by ACTUATED MEDICAL, INC.
- PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY) by Pentax Medical Company
- DISPOSABLE DISTAL ATTACHMENT D-201-16403 by Olympus Medical Systems Corporation
- DISPOSABLE DISTAL ATTACHMENT D-201-12402 by Olympus Medical Systems Corporation
- Fujifilm Endoscope Model EG-740N by FUJIFILM CORPORATION
- EvoEndo Single-Use Endoscopy System by Evoendo, Inc.
- EG-3630UR, ULTRASUND VIDEO GASTROSCOPE by Pentax Precision Instrument Corp.
- Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2 by FUJIFILM CORPORATION
- OLYMPUS DISTAL ATTACHMENT, MODELS MH-462, -463, -464, -465, -466, -483, -587, -588, -589, -590, -591, -592, -593, -594, -595, -596, -597 by Olympus America, Inc.