Flexiflo Tube Placement Verifier
by Abbott Laboratories 510(k)
Active
510(k) K922216
Overview
The Flexiflo Tube Placement Verifier is a device classified under Tubes, Gastrointestinal (and Accessories). It is designed to verify the correct placement of enteral feeding tubes, ensuring they are positioned accurately within the gastrointestinal tract to prevent complications such as aspiration or misplacement.
This device is intended for single-use in clinical settings, including gastroenterology and urology procedures. It is supplied sterile and requires no special storage conditions beyond standard medical device protocols. The Flexiflo Tube Placement Verifier holds an FDA 510(k) clearance (K922216) under the KNT product code, with a decision date of January 9, 1995, and is classified as substantially equivalent (SESE).
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK922216 | Date9 Jan 1995 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KNT
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5980
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Abbott Laboratories
Questions
What is the Flexiflo Tube Placement Verifier used for?
The Flexiflo Tube Placement Verifier is designed to confirm the correct positioning of enteral feeding tubes within the gastrointestinal tract. Proper placement is critical to avoid complications such as aspiration or misplacement, which can occur if the tube is incorrectly inserted. This device helps clinicians verify tube location before initiating feeding or medication administration.
Is the Flexiflo Tube Placement Verifier intended for single-use or reuse?
This device is explicitly intended for single-use only. Its design and sterile packaging ensure safety and reliability for one-time clinical use, reducing the risk of cross-contamination or device degradation from repeated use. Discard after use to comply with infection control protocols.
How is the Flexiflo Tube Placement Verifier supplied, and what storage requirements apply?
The Flexiflo Tube Placement Verifier is supplied sterile, ready for immediate clinical use without additional preparation. No special storage conditions are required beyond standard medical device protocols—store in a clean, dry environment away from direct sunlight or extreme temperatures. Follow facility guidelines for sterile supply management.
Which clinical specialties commonly use this device?
This device is primarily utilized in gastroenterology and urology procedures, where enteral feeding tubes are frequently placed. Clinicians in these specialties rely on accurate tube placement verification to ensure patient safety during feeding, medication delivery, or diagnostic interventions.
What regulatory clearance does the Flexiflo Tube Placement Verifier hold?
The device holds FDA 510(k) clearance under the KNT product code, with a clearance number of K922216. It was determined to be substantially equivalent (SESE) to a legally marketed predicate device, as reviewed by the FDA’s Gastroenterology and Urology (GU) Advisory Committee in 1995. This clearance confirms its compliance with U.S. regulatory standards for safety and effectiveness.