# K021856: Porges Ureteral Catheters, Models ACN6XX, ACN5XX, AC5B, AC5C07, ACP5XX, ACP2XX, ACP3XX, ACP4XX, ACP6XX

- Pathway: 510(k) (Traditional)
- Applicant: Porges S.A.
- Decided: Oct 17, 2002 after 133 days
- Product code: EYB (Catheter, Ureteral, Gastro-Urology)
- Device class: 2
- Regulation: 21 CFR 876.5130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K950300 (1995). 1 ancestor in all.
5 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950300: Bard Flexible Tip Ureteral Catheter, C.R. Bard, Inc. (1995) Summary page 1.
- (no number) PORGES pre-amendment range of ureteral catheters: named in the summary without a submission number
- (no number) C.R. Bard Inc. currently marketed ureteral catheter line: named in the summary without a submission number

## Most influential descendants
- K171662: Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Tip Ureteral Access Catheter, Pediatric Ureteral Catheter (2018), 2 descendants of its own
- K182122: Ureteric Catheters (2018), 1 descendant of its own
- K220036: Wellead Ureteral Catheter (2022), 0 descendants of its own
- K192183: RocaTub Ureteral Catheter (2020), 0 descendants of its own
- K191187: Dornier MINNOW Ureteral Catheter (2019), 0 descendants of its own

## Indications for use
The PORGES Ureteral catheters are used for ureteral catheterisation: - drainage catheters: straight catheters with bevel, olive or cylindrical tip, elbowed catheter with olive tip - catheters for retrograde ureteropyelography (R.U.P.):Chevassu, cone or Braasch - interventional catheters: flush, open straight, open elbowed. The appropriate guide-wire size for each catheter is shown on the box.

Source page: https://510kreport.com/device/K021856
Methodology: https://510kreport.com/methodology