Hemastick 1-1.5 & 2-Dispos. Blood
510(k) K833816
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK833816 | Date22 Dec 1983 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- FMK
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4850
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
The device is a lancet for blood sampling, as defined by its classification name and product code FMK. It is substantially equivalent to a predicate device and received traditional 510(k) clearance from the FDA.
It is supplied by Medprobe Laboratories and was cleared for marketing on December 22, 1983, under K833816. The device is intended for general and plastic surgery applications, as indicated by the review panel designation.
Other devices from Medprobe Laboratories
Questions
AI-generated answers, 6 Oct 2026
What is the Hemastick used for?
The Hemastick is used for blood sampling in general and plastic surgery applications.
Is the Hemastick disposable?
Yes, the Hemastick is a disposable lancet for blood sampling.
What type of clearance did the Hemastick receive from the FDA?
The Hemastick received traditional 510(k) clearance from the FDA, indicating it is substantially equivalent to a predicate device.