Colonoscope, 2-CHANNEL Log (Acmi TX-92)
FDA 510(k) K760452 · American Cystocope Makers, Inc.
510(k) numberK760452
Submission
- Device name
- Colonoscope, 2-CHANNEL Log (Acmi TX-92)
- Applicant
- American Cystocope Makers, Inc.
Mchenry, IL, US - Received
- August 16, 1976
- Decision date
- August 30, 1976
- 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).
Other 510(k)s with product code FDF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K832040 | Sterile Fluid Producing Unit #EP550LJH · Traditional | 09/29/1983SE |
| K812637 | Acmi Bipolar Hemostatic SourceGEI · Traditional | 10/26/1981SE |
| K811218 | Acmi Aspirator Kit #8808EOQ · Traditional | 07/01/1981SE |
| K803214 | Acmi Bipolar Hemostatic ElectrodeFEH · Traditional | 01/15/1981SE |
| K791182 | Acmi Rigi-Flex NephorscopeFGA · Traditional | 07/30/1979SE |
| K770754 | Duodenoscope, Molel TX-6FOG · Traditional | 04/28/1977SE |
| K760822 | Model TX-8 PanendoscopeFAK · Traditional | 10/21/1976SE |
| K760451 | Air Water Source (Acmi Model 710)OCX · Traditional | 08/30/1976SE |
Questions and answers
When was Colonoscope, 2-CHANNEL Log (Acmi TX-92) cleared by the FDA?
Colonoscope, 2-CHANNEL Log (Acmi TX-92) (K760452) received a 510(k) decision of Substantially Equivalent on August 30, 1976, 14 days after the submission was received.
What is the product code of K760452?
The FDA product code is FDF – Colonoscope And Accessories, Flexible/Rigid, a Class II (moderate risk) device regulated under 21 CFR 876.1500.