510(k) · Cleared
ClearedLina Gold Loop HC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lina Medical Aps · KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Cleared on Jan 31, 2014 as substantially equivalent to K070315 (Lina Medical Aps, 2007) after a 205-day review. Its family tree reaches back 3 generations to 1985.
- Decided
- Jan 31, 2014
- Review
- 205 days
- Class
- Class II
- Product code
- KNF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K851958 (1985). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK851958 Rotatable Polypectomy Snare Pos-1Wilson-Cook Medical, Inc. · 1985 · Recalled
- 2 generations backK050294 Cook Ireland Sonnet Polypectomy SnareCook Ireland, Ltd. · 2005
- 1 generation backK070315 Lina Loop, Models: EL-160-4, EL-160-8, EL-200-4, EL-200-8Lina Medical Aps · 2007 · Recalled
- This deviceK132135 Lina Gold Loop HCLina Medical Aps · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K851958 | Rotatable Polypectomy Snare Pos-1 | Wilson-Cook Medical, Inc. | 1985 | 3 |
| −2 | K050294 | Cook Ireland Sonnet Polypectomy Snare | Cook Ireland, Ltd. | 2005 | — |
| −1 | K070315 | Lina Loop, Models: EL-160-4, EL-160-8, EL-200-4, EL-200-8 | Lina Medical Aps | 2007 | 3 |
| 0 (this device) | K132135 | Lina Gold Loop HC | Lina Medical Aps | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 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 KNF? 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 KNF device
- #1 K240503 Sonata Transcervical Fibroid Ablation System 2.2score 13.7 · 11 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 |
|---|---|---|---|
| * | K070315 | Lina Loop, Models: EL-160-4, EL-160-8, EL-200-4, EL-200-8Summary page 1…Class II Classification Panel: Obstetrics and Gynecology Panel 5. Predicate Devices to which S.E is claimed: LiNA Loop K0703 15 6. Device Description The LiNA Gold Loop I-IC is a 5 min single use laparoscopic instrumnent. It is available with three d… | 2007 |
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 29 years and passes through 3 companies; a new generation was cleared every 6.3 years on median.
- 2 of the 5 ancestors have a recall of any class.
- 4 other devices also cite its predicate K070315.
How does its category compare?
All KNF devicesKNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · KNF
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNF
Too few KNF 510(k)s in any year since 2007 to give a median.
Recalls per year · KNF
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KNF
93in 2025
MAUDE reports naming product code KNF, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 2 |
| 2009 | 0 | — | 3 | 1 |
| 2010 | 1 | — | 0 | 14 |
| 2011 | 0 | — | 0 | 15 |
| 2012 | 1 | — | 0 | 4 |
| 2013 | 1 | — | 1 | 24 |
| 2014 | 1 | — | 0 | 8 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 0 | — | 0 | 9 |
| 2017 | 0 | — | 0 | 22 |
| 2018 | 1 | — | 0 | 13 |
| 2019 | 0 | — | 0 | 18 |
| 2020 | 1 | — | 0 | 19 |
| 2021 | 1 | — | 0 | 9 |
| 2022 | 1 | — | 0 | 16 |
| 2023 | 1 | — | 0 | 33 |
| 2024 | 1 | — | 0 | 13 |
| 2025 | 1 | — | 0 | 93 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The LINA Gold Loop HC is a 5mm monopolar electrosurgical device intended for culling and removal of soft tissue in gynecological procedures involving endoscopic hysterectomy. It is used with standard electrosurgical generators.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132135 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132135: Lina Gold Loop HC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132135
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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