Duoflo Dispenser
510(k) K872565
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK872565 | Date29 Dec 1987 | 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- Withdrawn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
- FMF
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.5860
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Duoflo Dispenser is a medical device classified as a syringe, piston. It is used to simultaneously apply two-part reactive material and surgical preparations.
The Duoflo Dispenser is supplied empty and is a single device with the product code FMF. It has FDA 510K clearance with the k number K872565, and is classified as a class 2 device with the regulation number 880.5860.
Questions
AI-generated answers, 1 Oct 2026
What is the Duoflo Dispenser used for?
The Duoflo Dispenser is used to simultaneously apply two-part reactive material and surgical preparations, making it a versatile tool in medical settings.
Is the Duoflo Dispenser supplied sterile?
The Duoflo Dispenser is supplied empty, but its sterility status is not specified, so users should follow proper sterilization procedures before use.
Is the Duoflo Dispenser reusable?
The Duoflo Dispenser is described as a single device, implying it is intended for single-use, but specific reuse guidelines are not provided.