Model TX-8 Panendoscope
FDA 510(k) K760822 · American Cystocope Makers, Inc.
510(k) numberK760822
Submission
- Device name
- Model TX-8 Panendoscope
- Applicant
- American Cystocope Makers, Inc.
Mchenry, IL, US - Received
- October 13, 1976
- Decision date
- October 21, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FAK – Panendoscope (Gastroduodenoscope)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type 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 FAK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K812810 | Pentax Flexible DriodenofiberscopeFAK · Traditional | Pentax Precision Instrument Corp. | 11/17/1981SE |
More from Pentax Precision Instrument Corp.
| 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 |
| K760452 | Colonoscope, 2-CHANNEL Log (Acmi TX-92)FDF · Traditional | 08/30/1976SE |
| K760451 | Air Water Source (Acmi Model 710)OCX · Traditional | 08/30/1976SE |
Questions and answers
When was Model TX-8 Panendoscope cleared by the FDA?
Model TX-8 Panendoscope (K760822) received a 510(k) decision of Substantially Equivalent on October 21, 1976, 8 days after the submission was received.
What is the product code of K760822?
The FDA product code is FAK – Panendoscope (Gastroduodenoscope), a Class II (moderate risk) device regulated under 21 CFR 876.1500.