Tubing Feeding Kit
by Doyle Pharmaceutical 510(k)
Active
510(k) K770620
Overview
A tubing feeding kit is a tube, feeding device used for enteral nutrition delivery. It is classified as a Class II medical device under regulation 876.5980 with product code FPD.
The device was cleared via the traditional 510(k) pathway (K770620) by Doyle Pharmaceutical, with a substantially equivalent decision dated May 3, 1977. It is intended for use in gastroenterology and urology settings and is supplied as a non-sterile, reusable or single-use component kit depending on configuration, though specific sterility and usage details are not provided in the data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK770620 | Date3 May 1977 | 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- Withdrawn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
- FPD
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5980
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Questions
What is the tubing feeding kit used for?
The tubing feeding kit is a tube feeding device used for enteral nutrition delivery, intended for use in gastroenterology and urology settings as specified in its FDA 510(k) clearance.
How is the tubing feeding kit supplied and is it sterile or reusable?
The device is supplied as a non-sterile, reusable or single-use component kit depending on configuration, though specific sterility and usage details are not provided in the data.
What regulatory pathway was used to clear the tubing feeding kit and when was it cleared?
The tubing feeding kit was cleared via the traditional 510(k) pathway (K770620) by Doyle Pharmaceutical, with a substantially equivalent decision dated May 3, 1977.