Sheath, Corrugated Rubber, For Nonindwelling Catheter, Sterile
The corrugated rubber sheath for nonindwelling catheter is a sterile flexible external sheath placed over a catheter to provide protection and assist in its introduction or use in urological procedures, particularly in non-indwelling catheterization. It is classified as FDA Class 1, the lowest risk category, requiring only general controls. The product code is EYT, regulated under 21 CFR 876.5250 in the Gastroenterology, Urology specialty. No special regulatory flags apply.
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Basic Information
- Product Code
- EYT
- Device Class
- FDA class 1
- Regulation Number
- 876.5250
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K934080 | URINARY DRAINAGE BAG | May 18, 1994 | Substantially Equivalent | Kit Pak, Inc. |
| K935774 | CURITY FAST-CATH FEMALE CATHETER KIT | Apr 11, 1994 | Unknown | Kendall Healthcare Products Co. Div.Of Tyco Health |
| K883119 | VPI NON-ADHESIVE CONDOM CATHETER | Aug 02, 1988 | Substantially Equivalent | Cook Urological, Inc. |
| K883057 | COMFORT CATH MALE EXTERNAL CATHETER | Aug 02, 1988 | Substantially Equivalent | Sierra Laboratories, Inc. |
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.