FUJIFILM Endoscope Model EC-760Z-V/L
FDA 510(k) K192664 · Fujifilm Corporation
510(k) numberK192664
Submission
- Device name
- FUJIFILM Endoscope Model EC-760Z-V/L
- Applicant
- Fujifilm Corporation
Ashigara Kami-Gun, JP - Received
- September 25, 2019
- Decision date
- November 20, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FDF – Colonoscope 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 colon or rectum 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).
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|---|---|---|---|
| K260503 | Triton 1 SystemFDF · Traditional | Neptune Medical, Inc. | 09/03/2026SE |
| K261015 | Solo Scope Colonoscope SystemFDF · Traditional | Gi View, Ltd. | 08/21/2026SE |
| K261587 | Insufflation Retention Device (IRD) (11173-325-101)FDF · Special | BPEndo, LLC | 07/02/2026SE |
| K260423 | Disposable Endoscopic Distal AttachmentsFDF · Traditional | Yangzhou Fartley Medical Instrument Technology… | 05/28/2026SE |
| K252457 | Disposable Distal End Tape HoodFDF · Traditional | Shanghai SeeGen Photoelectric Technology Co., Ltd. | 01/30/2026SE |
| K244029 | Robopera (ER-R-002); Robopera (ER-R-003)FDF · Traditional | Endorobotics Co., Ltd. | 09/24/2025SE |
| K243261 | FUJIFILM Endoscope Model EC-860P/M; FUJIFILM Endoscope Model EC-860P/L; FUJIFILM…FDF · Traditional | Fujifilm Corporation | 05/23/2025SE |
| K250432 | Colonovideoscope (CF-EZ1500DL); Colonovideoscope (CF-EZ1500DI); Gastrointestinal…FDF · Traditional | Olympus Medical Systems Corporation | 05/15/2025SE |
| K242110 | PENTAX Medical Video Colonoscope (EC38-i20cWL)FDF · Traditional | Pentax of America, Inc. | 01/03/2025SE |
| K242325 | GripTract-GI Endoscopic Tissue Manipulator Lower GI ModelsFDF · Traditional | Actuated Medical, Inc. | 10/04/2024SE |
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|---|---|---|
| K253836 | FCT iStream Phase 2JAK · Traditional | 09/04/2026SE |
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| K260567 | EW10-EC02 Endoscopy Support ProgramQNP · Special | 08/07/2026SE |
| K261880 | FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01FET · Special | 07/02/2026SE |
| K253137 | FUJIFILM Endoscope Model EB-840S; FUJIFILM Endoscope Model EB-840TEOQ · Traditional | 06/16/2026SE |
| K254075 | Synapse Lung Nodule AIOEB · Traditional | 05/27/2026SE |
| K254189 | Synapse 3D Base Tools (V7.2)QIH · Traditional | 04/30/2026SE |
| K253862 | APERTO Lucent MRI SystemLNH · Traditional | 04/06/2026SE |
| K251861 | FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM…FDT · Traditional | 03/09/2026SE |
| K250550 | FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display UnitFDS · Traditional | 02/17/2026SE |
Questions and answers
When was FUJIFILM Endoscope Model EC-760Z-V/L cleared by the FDA?
FUJIFILM Endoscope Model EC-760Z-V/L (K192664) received a 510(k) decision of Substantially Equivalent on November 20, 2019, 56 days after the submission was received.
What is the product code of K192664?
The FDA product code is FDF – Colonoscope And Accessories, Flexible/Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.