KYP · Snake Bite Suction Kit
General Hospital · 21 CFR 880.5740 · Class 1
Overview
| Product Code | KYP |
|---|---|
| Device Name | Snake Bite Suction Kit |
| Regulation | 21 CFR 880.5740 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
Identification
A suction snakebite kit is a device consisting of a knife, suction device, and tourniquet used for first-aid treatment of snakebites by removing venom from the wound.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K883839 | ND:YAG LASER SPECTACLES, MST MODEL #YLS-5 | Marlo Surgical Technology | Dec 9, 1988 | SESE |
| K844048 | DR. HESSEL'S INSECT POISON REMOVER | Medie Group | Jan 23, 1985 | SESE |
| K842015 | SAWYER FIRST AID KIT | Saffeta, Inc. | Jul 6, 1984 | SESE |
| K831312 | LOPEZ-HORN CARRIER | Chiron Vision Corp. | May 25, 1983 | SESE |
Top Applicants
- Chiron Vision Corp. — 1 clearance
- Marlo Surgical Technology — 1 clearance
- Medie Group — 1 clearance
- Saffeta, Inc. — 1 clearance
