Micro Z Blood Collecting Needles
510(k) K823696
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK823696 | Date26 Jan 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- Withdrawn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
- FMI
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5570
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
Micro Z Blood Collecting Needles are blood collection needles used for obtaining blood specimens. They are designed for venipuncture procedures in clinical settings.
These needles are supplied sterile and intended for single-use only. They are regulated under FDA 510(k) clearance K823696, with product code FMI, and were cleared for marketing on January 26, 1983.
Other devices from Hospital Products Co.
Questions
AI-generated answers, 1 Oct 2026
What is the Micro Z Blood Collecting Needle used for?
The Micro Z Blood Collecting Needle is used for obtaining blood specimens through venipuncture procedures in clinical settings, as it is specifically designed for this purpose to ensure safe and effective sample collection.
How is the Micro Z Blood Collecting Needle supplied and is it reusable?
The Micro Z Blood Collecting Needle is supplied sterile and is intended for single-use only, meaning it should be discarded after one procedure to prevent cross-contamination and ensure patient safety.
What regulatory clearance does the Micro Z Blood Collecting Needle have?
The Micro Z Blood Collecting Needle is regulated under FDA 510(k) clearance K823696, which was granted on January 26, 1983, based on a determination of substantial equivalence to a legally marketed predicate device.