Leg Bag
by Abco Dealers, Inc. 510(k)
Active
510(k) K780878
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK780878 | Date31 Jul 1978 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
- KNX
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5250
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 25 Sep 2026
A leg bag is a collector, urine, (and accessories) for indwelling catheter. It is classified as a Class II medical device under product code KNX.
The device was cleared via the FDA 510(k) process under K780878 by Abco Dealers, Inc. It received a substantially equivalent decision on July 31, 1978, following a traditional review.
Other devices from Abco Dealers, Inc.
Questions
AI-generated answers, 25 Sep 2026
What is the LEG BAG used for?
The LEG BAG is a collector designed to collect urine from indwelling catheters, serving as a drainage device for patients requiring continuous urinary drainage.
How was the LEG BAG cleared for market distribution?
The LEG BAG received clearance through the FDA 510(k) process under submission K780878, with a substantially equivalent determination granted on July 31, 1978, following a traditional review pathway.
What regulatory classification and product code apply to the LEG BAG?
The LEG BAG is classified as a Class II medical device under FDA product code KNX, which corresponds to 'Collector, Urine, (And Accessories) For Indwelling Catheter' as defined in the device listing.