Ao Flexible Fiber Optic S/Colonoscope
FDA 510(k) K792179 · American Optical Corp.
510(k) numberK792179
Submission
- Device name
- Ao Flexible Fiber Optic S/Colonoscope
- Applicant
- American Optical Corp.
Mchenry, IL, US - Received
- October 29, 1979
- Decision date
- December 6, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
More from Actuated Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K950881 | Phaco TipHQC · Traditional | 09/06/1995SE |
| K950880 | Aoi Universal Ultrasonic HandpieceHQC · Traditional | 05/26/1995SE |
| K931358 | AORP4000 Reusable PakHQC · Traditional | 02/22/1994SE |
| K931354 | P4000 PhacoemulsifierHQC · Traditional | 02/22/1994SE |
| K931357 | AOD4000 Disposable PakHQC · Traditional | 01/25/1994SE |
| K820790 | Flexible Proctosigmoidoscope, #FPS-3FAM · Traditional | 04/01/1982SE |
| K813430 | Tissue Processing Cassettes & AccessIDL · Traditional | 12/29/1981SE |
| K812965 | Model SC-6, Flexible SiamoidoscopeFAM · Traditional | 11/02/1981SE |
| K812051 | Photolite Aolite Tintomatic LensHQG · Traditional | 09/08/1981SE |
| K812063 | SR-1V Data PrinterHKO · Traditional | 08/18/1981SE |
Questions and answers
When was Ao Flexible Fiber Optic S/Colonoscope cleared by the FDA?
Ao Flexible Fiber Optic S/Colonoscope (K792179) received a 510(k) decision of Substantially Equivalent on December 6, 1979, 38 days after the submission was received.
What is the product code of K792179?
The FDA product code is FDF – Colonoscope And Accessories, Flexible/Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.