Enolok-For Endoscoped with 12.8>DIA.<13.3MM Shaft Diameter, Model Ael; Endoscopes with 11.3>DIA. 11.5MM Shaft ,Model Pel
FDA 510(k) K080317 · Syntheon, LLC
510(k) numberK080317
Submission
- Device name
- Enolok-For Endoscoped with 12.8>DIA.<13.3MM Shaft Diameter, Model Ael; Endoscopes with 11.3>DIA. 11.5MM Shaft ,Model Pel
- Applicant
- Syntheon, LLC
Miami, FL, US - Received
- February 6, 2008
- Decision date
- April 29, 2008
- 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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Questions and answers
When was Enolok-For Endoscoped with 12.8>DIA.<13.3MM Shaft Diameter, Model Ael; Endoscopes with 11.3>DIA. 11.5MM Shaft ,Model Pel cleared by the FDA?
Enolok-For Endoscoped with 12.8>DIA.<13.3MM Shaft Diameter, Model Ael; Endoscopes with 11.3>DIA. 11.5MM Shaft ,Model Pel (K080317) received a 510(k) decision of Substantially Equivalent on April 29, 2008, 83 days after the submission was received.
What is the product code of K080317?
The FDA product code is FDF – Colonoscope And Accessories, Flexible/Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.