Dilator, Catheter
The Dilator, Catheter (product code GCC) is a tapered instrument used to gradually enlarge or dilate a catheter tract, vessel, or body orifice to allow passage of a catheter or other device during general or plastic surgery. It is classified as FDA Class 1, posing minimal risk, requiring only general controls and no premarket notification. The device is regulated under 21 CFR 878.4200 in the General, Plastic Surgery specialty (SU). No special flags apply to this device.
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Basic Information
- Product Code
- GCC
- Device Class
- FDA class 1
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K981061 | INTRAVASCULAR RETRIEVAL DEVICE | May 26, 1998 | Substantially Equivalent | Med Institute, Inc. |
| K922354 | BYRD TELESCOPING STAINLESS STEEL DILAT SHEATH SET | Jul 30, 1992 | Substantially Equivalent | Med Institute, Inc. |
| K902502 | BYRD STAINLESS STEEL DILATOR | Aug 07, 1990 | Substantially Equivalent | Medical Engineering and Development Institute |
| K893480 | BYRD EXTRACTOR SET | Jun 23, 1989 | Substantially Equivalent | Medical Engineering and Development Institute |
| K820865 | VAN-TEC FASCIAL DILATOR | May 05, 1982 | Substantially Equivalent | Van-Tec, Inc. |
FEI Numbers
This FDA classification entry is associated with 101 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 101 registration numbers. Click on an entry to view related FDA registrations.