Sigmoidoscope, Rigid, Non-Electrical
A rigid, non-electrical sigmoidoscope is a tubular endoscopic instrument inserted through the anus and rectum to visually examine the sigmoid colon and rectum for pathology such as polyps, inflammatory changes, or malignancy, without incorporating an electrical light source. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket clearance demonstrating substantial equivalence to a predicate device. Product code KDM is regulated under 21 CFR 876.1500 in the Gastroenterology, Urology medical specialty. No additional special flags apply to this device.
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Basic Information
- Product Code
- KDM
- Device Class
- FDA class 2
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K070915 | SAPIMED DISPOSABLE SIGMOIDOSCOPE | Jul 06, 2007 | Substantially Equivalent | Sapimed S.P.A. |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.