Fiab Spa Models F7244, F7233, F7234, F7277
by Fiab SpA
510(k) K100333
Active
Valid until
Not listed
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK100333 | Date21 Jun 2010 | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA Product Code
- GEI
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4400
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Fiab Spa Models F7244, F7233, F7234, and F7277 are classified as surgical sutures, non-absorbable, monofilament, synthetic (product code GEI). These devices are designed for use in general and plastic surgery procedures, providing durable closure of soft tissues through precise, atraumatic wound approximation.
Supplied as sterile, single-use devices, these sutures are intended for intraoperative use in controlled surgical environments. Each model is manufactured to comply with FDA 510(k) clearance under the Traditional pathway and EU MDR requirements, ensuring adherence to regulatory standards for medical-grade sutures. Storage conditions must maintain sterility, and the devices are packaged for immediate clinical application without reprocessing.
Other devices from Fiab SpA
Questions
AI-generated answers, 18 Sep 2026
Are these sutures reusable, or are they meant for single-use only in surgery?
These sutures are designed for single-use only and are supplied sterile, packaged specifically for intraoperative use. The packaging ensures sterility and prevents reprocessing, making them suitable for one-time clinical application in controlled surgical environments.
What types of surgical procedures are these sutures intended for, and why?
These sutures are intended for general and plastic surgery procedures, particularly for soft tissue closure where durable, atraumatic wound approximation is required. Their monofilament, non-absorbable, synthetic design ensures minimal tissue reaction and long-term stability, making them ideal for procedures where prolonged wound integrity is critical.
How should I store these sutures to maintain their sterility and usability?
To maintain sterility, these sutures must be stored in their original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging is designed for immediate clinical use, so avoid opening or reprocessing, as this could compromise sterility and regulatory compliance.
What regulatory pathways have these sutures gone through, and what does that mean for me?
These sutures have undergone FDA 510(k) clearance under the Traditional pathway and comply with EU MDR requirements, confirming they meet established safety and performance standards for surgical sutures. The clearance indicates they are considered substantially equivalent to predicate devices, ensuring reliability for general and plastic surgery applications.
Are there different sizes or models available, and how do I choose the right one?
Yes, these sutures come in four distinct models (F7244, F7233, F7234, F7277), each likely designed for specific tissue types or suture techniques. While exact sizes or diameters aren’t specified here, the monofilament, non-absorbable nature suggests they may vary in gauge or length for different surgical needs. Consult the product documentation or manufacturer for guidance on selecting the appropriate model based on your procedure requirements.