Catheter, Rectal
The Catheter, Rectal (product code GBT) is a catheter inserted into the rectum for the purpose of administering fluids or medications, evacuating gas or feces, or facilitating other rectal procedures in gastroenterological or urological settings. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. The device is regulated under 21 CFR 876.5980 in the Gastroenterology, Urology specialty (GU). It is eligible for third-party 510(k) review by an FDA-accredited reviewer.
Basic Information
- Product Code
- GBT
- Device Class
- FDA class 2
- Regulation Number
- 876.5980
- 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 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K941391 | INFLATABLE RETENTION CUFF SPECULUM | Oct 20, 1994 | Substantially Equivalent | INNOVATEC MEDICAL CORP. |
| K924549 | TRI-MED QUICK-STEP(TM) RECTAL TUBE | Feb 10, 1994 | Substantially Equivalent | TRI-MED SPECIALTIES, INC. |
| K890466 | SIGMOID TONOMITOR | Apr 21, 1989 | Substantially Equivalent | TONOMETRICS, INC. |
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.