Conphar Silicone Drains-Sterile
by Conphar, Inc. 510(k)
Active
510(k) K791254
Overview
The Conphar Silicone Drains Sterile are medical-grade silicone drains designed for surgical wound drainage. Classified under product code KDQ, these devices are intended for use in general hospital settings to facilitate the removal of fluids, such as serous, sanguineous, or purulent drainage, from postoperative or traumatic wounds, abscesses, or other fluid collections. Their flexible, biocompatible silicone construction ensures minimal tissue irritation while maintaining patency for effective drainage.
These drains are supplied sterile and intended for single-use. They are regulated under FDA 510(k) clearance (K791254) and fall under the General Hospital advisory committee category. Available in standard sizes as specified in the submission, they require proper storage in a clean, dry environment to preserve sterility. No additional regulatory markings beyond the FDA clearance are indicated in the provided data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK791254 | Date3 Aug 1979 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- KDQ
- Device Class
- Class II
- Regulation
- 21 CFR Part 880.6740
- Advisory Committee
- General Hospital
- FDA Decision
- SESE Substantially Equivalent
Other devices from Conphar, Inc.
Questions
What are the Conphar Silicone Drains Sterile used for?
These drains are designed for surgical wound drainage in hospital settings. They help remove fluids like serous, sanguineous, or purulent drainage from postoperative wounds, traumatic injuries, abscesses, or other fluid collections. Their flexible, biocompatible silicone material reduces irritation while keeping the drainage pathway open for efficient fluid evacuation.
Are the Conphar Silicone Drains Sterile intended for single-use or reuse?
The Conphar Silicone Drains Sterile are explicitly supplied sterile and intended for single-use only. This ensures patient safety by preventing cross-contamination and maintains the device’s integrity for optimal performance during a single procedure.
How should these drains be stored to maintain sterility?
To preserve sterility, these drains must be stored in a clean, dry environment away from direct sunlight or moisture. The packaging should remain intact until immediate preoperative use. Avoid exposure to extreme temperatures or contaminants, as this could compromise the sterile barrier.
What sizes are available for the Conphar Silicone Drains Sterile?
The device is available in standard sizes, as specified in the FDA submission (product code KDQ). Exact dimensions or variations (e.g., length, diameter) are not detailed in the provided data, but the design prioritizes flexibility and biocompatibility for general wound drainage applications.
Do these drains require any special handling beyond standard sterile procedures?
Beyond adhering to standard sterile surgical protocols, no additional handling requirements are noted in the provided data. The drains are pre-sterilized and packaged for immediate use. Clinicians should follow manufacturer guidelines for proper insertion, securing, and disposal to prevent occlusion or infection.