Snake Bite Suction Kit
The Snake Bite Suction Kit is a first-aid convenience kit containing a suction device used to attempt mechanical extraction of venom from a snake bite wound in emergency situations. It is classified as FDA Class 1, the lowest risk category, subject to general controls only; this product code was established under the May 20, 1997, convenience kits interim regulatory guidance, and kits meeting all criteria in that guidance are under enforcement discretion and do not require a 510(k) to market. The product code is KYP, regulated under 21 CFR 880.5740, in the General Hospital medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- KYP
- Device Class
- FDA class 1
- Regulation Number
- 880.5740
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 7
Device Characteristics
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.
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 |
|---|---|---|---|---|
| K883839 | ND:YAG LASER SPECTACLES, MST MODEL #YLS-5 | Dec 09, 1988 | Substantially Equivalent | Marlo Surgical Technology |
| K844048 | DR. HESSEL'S INSECT POISON REMOVER | Jan 23, 1985 | Substantially Equivalent | Medie Group |
| K842015 | SAWYER FIRST AID KIT | Jul 06, 1984 | Substantially Equivalent | Saffeta, Inc. |
| K831312 | LOPEZ-HORN CARRIER | May 25, 1983 | Substantially Equivalent | Chiron Vision Corp. |
FEI Numbers
This FDA classification entry is associated with 16 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 16 registration numbers. Click on an entry to view related FDA registrations.