# K812057: Vance Cystoscopic

- Pathway: 510(k) (Traditional)
- Applicant: Vance Products, Inc.
- Decided: Jul 31, 1981 after 10 days
- Product code: FBK (Endoscopic Injection Needle, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
13 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K022484: Cook Injection Needle (2002), 12 descendants of its own
- K090830: Laborie Injetak Adjustable Tip Needle, Flexible Tip and Ridgid Tip (2009), 3 descendants of its own
- K090217: Bonee Needle for Bladder Injections, MODELSNBI035, NBI070 (2009), 2 descendants of its own
- K192498: Single Use Injector (2020), 1 descendant of its own
- K180214: Repris Bladder Injection System (2018), 1 descendant of its own

Source page: https://510kreport.com/device/K812057
Methodology: https://510kreport.com/methodology