510(k) · Cleared
ClearedLiNA OperaScope Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lina Medical Aps · FBK Endoscopic Injection Needle, Gastroenterology-Urology
Cleared on Sep 2, 2022 as substantially equivalent to K022484 (Cook Urological, Inc., 2002) after a 142-day review. Its family tree reaches back 5 generations to 1982.
- Decided
- Sep 2, 2022
- Review
- 142 days
- Class
- Class II
- Product code
- FBK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K820973 (1982). 9 ancestors in all, the oldest K812057 (1981). No later device cites it as a predicate yet.
- Root · 5 generations backK820973 Endoscopic Injection NeedleMill-Rose Laboratory · 1982
- 4 generations backK960519 Martech Endoscopic Injection NeedleMartech Medical Products, Inc. · 1996
- 3 generations backK982890 Advanced Uroscience Injection NeedleAdvanced Uroscience, Inc. · 1998
- 2 generations backK990996 Genyx Medical Injection NeedleGenyx Medical, Inc. · 1999
- 1 generation backK022484 Cook Injection NeedleCook Urological, Inc. · 2002
- This deviceK221085 LiNA OperaScope NeedleLina Medical Aps · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K820973 | Endoscopic Injection Needle | Mill-Rose Laboratory | 1982 | — |
| −4 | K960519 | Martech Endoscopic Injection Needle | Martech Medical Products, Inc. | 1996 | — |
| −3 | K982890 | Advanced Uroscience Injection Needle | Advanced Uroscience, Inc. | 1998 | — |
| −2 | K990996 | Genyx Medical Injection Needle | Genyx Medical, Inc. | 1999 | — |
| −1 | K022484 | Cook Injection Needle | Cook Urological, Inc. | 2002 | — |
| 0 (this device) | K221085 | LiNA OperaScope Needle | Lina Medical Aps | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1993 | 1 | 0 |
| 1998 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FBK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FBK device
- #1 K253598 InjecSURE Injection Systemscore 12.9 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K022484 | Cook Injection NeedleSummary page 4…rketed Predicate Device(s) Through FDA database search following predicate device has been identified: Cook Injection Needles manufactured by Cook Urological, Inc (K022484). No design-related recalls for these legally marketed predicate devices have been identified.… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 40 years and passes through 6 companies; a new generation was cleared every 3.4 years on median.
- None of the 9 ancestors has a recall.
- 5 other devices also cite its predicate K022484.
How does its category compare?
All FBK devicesFBK Endoscopic Injection Needle, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · FBK
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FBK
155in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FBK
9in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FBK
81in 2025
MAUDE reports naming product code FBK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 3 |
| 2008 | 1 | — | 0 | 22 |
| 2009 | 4 | 101 | 0 | 12 |
| 2010 | 0 | — | 0 | 12 |
| 2011 | 1 | — | 0 | 2 |
| 2012 | 2 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 2 | — | 0 | 9 |
| 2015 | 3 | 103 | 0 | 4 |
| 2016 | 2 | — | 1 | 18 |
| 2017 | 3 | 51 | 0 | 27 |
| 2018 | 2 | — | 0 | 9 |
| 2019 | 1 | — | 0 | 6 |
| 2020 | 2 | — | 0 | 25 |
| 2021 | 1 | — | 20 | 34 |
| 2022 | 6 | 213 | 8 | 80 |
| 2023 | 3 | 177 | 1 | 60 |
| 2024 | 4 | 192 | 9 | 94 |
| 2025 | 3 | 155 | 0 | 81 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
LiNA OperaScope™ Needle is intended for hysteroscopic injection into the uterine wall as well as for cystoscopic injection in the urinary bladder wall.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221085 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221085: LiNA OperaScope Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221085
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026