KYP — Snake Bite Suction Kit Class I
FDA product code KYP covers "Snake Bite Suction Kit", a Class I medical device regulated under 21 CFR 880.5740. Submissions are reviewed by the General Hospital panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KYP
- Device Class
- Class I
- Regulation Number
- 880.5740
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General Hospital
- Implant
- No
Definition
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K883839 | marlo surgical technology | ND:YAG LASER SPECTACLES, MST MODEL #YLS-5 | December 9, 1988 |
| K844048 | medie group | DR. HESSEL'S INSECT POISON REMOVER | January 23, 1985 |
| K842015 | saffeta | SAWYER FIRST AID KIT | July 6, 1984 |
| K831312 | chiron vision | LOPEZ-HORN CARRIER | May 25, 1983 |