# K221085: LiNA OperaScope Needle

- Pathway: 510(k) (Traditional)
- Applicant: Lina Medical Aps
- Decided: Sep 2, 2022 after 142 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
Longest line of descent: 5 generations back to K820973 (1982). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022484: Cook Injection Needle, Cook Urological, Inc. (2002) Summary page 4.

## Indications for use
LiNA OperaScope™ Needle is intended for hysteroscopic injection into the uterine wall as well as for cystoscopic injection in the urinary bladder wall.

Source page: https://510kreport.com/device/K221085
Methodology: https://510kreport.com/methodology