Intuitive Endoluminal Gastrointestinal System (IG1000)
FDA 510(k) K253702 · Intuitive Surgical, Inc.
510(k) numberK253702
Submission
- Device name
- Intuitive Endoluminal Gastrointestinal System (IG1000)
- Applicant
- Intuitive Surgical, Inc.
Sunnyvale, CA, US - Received
- November 24, 2025
- Decision date
- August 7, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FDS – Gastroscope And Accessories, Flexible/Rigid
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To examine or perform procedures in the stomach. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Other 510(k)s with product code FDS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260856 | Disposable Distal Attachment D-201-13404FDS · Traditional | Olympus Medical Systems Corporation | 08/27/2026SE |
| K260824 | Gastrointestinal Videoscope Olympus GIF-2T1500FDS · Traditional | Olympus Medical Systems Corporation | 08/27/2026SE |
| K260573 | EvoEndo Single-Use Endoscopy SystemFDS · Traditional | EvoEndo, Inc. | 04/21/2026SE |
| K250550 | FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display UnitFDS · Traditional | Fujifilm Corporation | 02/17/2026SE |
| K253568 | Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood…FDS · Special | Fujifilm Corporation | 02/06/2026SE |
| K251256 | PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video…FDS · Traditional | Pentax of America, Inc. | 12/16/2025SE |
| K251041 | GripTract-GI Endoscopic Tissue Manipulator Upper GI Model GT-GS100FDS · Traditional | Actuated Medical, Inc. | 10/31/2025SE |
| K251708 | EvoEndo Single-Use Endoscopy SystemFDS · Traditional | EvoEndo, Inc. | 10/10/2025SE |
| K243388 | Disposable Distal CapFDS · Traditional | Micro-Tech (Nanjing) Co., Ltd. | 06/27/2025SE |
| K250900 | EvoEndo Single-Use Endoscopy SystemFDS · Traditional | EvoEndo, Inc. | 06/16/2025SE |
More from EvoEndo, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K261823 | da Vinci Surgical System, Model IS5000NAY · Traditional | 09/08/2026SE |
| K261824 | da Vinci Surgical System, Model IS5000NAY · Traditional | 07/31/2026SE |
| K261249 | Universal Seal (5-12 mm)GCJ · Traditional | 07/14/2026SE |
| K260695 | da Vinci Firefly Imaging SystemNAY · Traditional | 05/22/2026SE |
| K253986 | da Vinci Force Feedback InstrumentsNAY · Traditional | 03/11/2026SE |
| K253978 | Universal Seal (5-12 mm)GCJ · Traditional | 02/24/2026SE |
| K253556 | da Vinci SP Surgical System (SP1098); da Vinci E-200 GeneratorNAY · Traditional | 01/16/2026SE |
| K251739 | da Vinci Surgical System (IS5000)NAY · Traditional | 01/16/2026SE |
| K251763 | IRISegQIH · Traditional | 12/16/2025SE |
| K252675 | da Vinci SP Surgical System (SP1098)NAY · Traditional | 12/15/2025SE |
Questions and answers
When was Intuitive Endoluminal Gastrointestinal System (IG1000) cleared by the FDA?
Intuitive Endoluminal Gastrointestinal System (IG1000) (K253702) received a 510(k) decision of Substantially Equivalent on August 7, 2026, 256 days after the submission was received.
What is the product code of K253702?
The FDA product code is FDS – Gastroscope And Accessories, Flexible/Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.