510(k) · Cleared
Recalled · 2009Lina Loop, Models: EL-160-4, EL-160-8, EL-200-4, EL-200-8
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 Oct 30, 2007 as substantially equivalent to K981464 (Omnitech Systems, Inc., 1998) and 1 other predicate after a 271-day review. Its family tree reaches back 2 generations to 1985. 7 later devices descend from it. It has been recalled 3 times.
- Decided
- Oct 30, 2007
- Review
- 271 days
- Class
- Class II
- Product code
- KNF
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 2 generations to K851958 (1985). 4 ancestors in all. 7 later devices descend from it, 5 citing it directly.
- Root · 2 generations backK851958 Rotatable Polypectomy Snare Pos-1Wilson-Cook Medical, Inc. · 1985 · Recalled
- 1 generation backK050294 Cook Ireland Sonnet Polypectomy SnareCook Ireland, Ltd. · 2005
- This deviceK070315 Lina Loop, Models: EL-160-4, EL-160-8, EL-200-4, EL-200-8Lina Medical Aps · 2007
- Descendant · cites it directly · 3 of its ownK111059 Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill)Gyrus Acmi, Inc. · 2011
- Descendant · 2 generations on · 1 of its ownK122605 PKS BillGyrus Acmi, Inc. · 2012
- Descendant · cites it directly · 0 of its ownK254303 Karl Storz SupraloopKarl Storz SE & CO. KG · 2026
- Descendant · 2 generations on · 0 of its ownK142525 PK Lap LoopOlympus Winter & Ibe GmbH · 2014
- Descendant · cites it directly · 0 of its ownK132135 Lina Gold Loop HCLina Medical Aps · 2014
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K111059Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill)Gyrus Acmi, Inc. · 2011 · cites it directly3descendants
- K122605PKS BillGyrus Acmi, Inc. · 2012 · 2 generations on1descendant
- K254303Karl Storz SupraloopKarl Storz SE & CO. KG · 2026 · cites it directly0descendants
- K142525PK Lap LoopOlympus Winter & Ibe GmbH · 2014 · 2 generations on0descendants
- K132135Lina Gold Loop HCLina Medical Aps · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K851958 | Rotatable Polypectomy Snare Pos-1 | Wilson-Cook Medical, Inc. | 1985 | 3 |
| −1 | K050294 | Cook Ireland Sonnet Polypectomy Snare | Cook Ireland, Ltd. | 2005 | — |
| 0 (this device) | K070315 | Lina Loop, Models: EL-160-4, EL-160-8, EL-200-4, EL-200-8 | Lina Medical Aps | 2007 | — |
| +1 | K111059 | Gyrus Acmil Bipolarlaproscopic Loop (PKS Bill) | Gyrus Acmi, Inc. | 2011 | — |
| +2 | K122605 | PKS Bill | Gyrus Acmi, Inc. | 2012 | — |
| +1 | K254303 | Karl Storz Supraloop | Karl Storz SE & CO. KG | 2026 | — |
| +2 | K142525 | PK Lap Loop | Olympus Winter & Ibe GmbH | 2014 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2026 | 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? (2)
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 |
|---|---|---|---|
| * | K981464 | Omnitech Resectoscope Cutting Loop ElectrodeSummary page 1…rosurgical generators that have a monopolar outlet. Substantial Equivalence The LiNA Loop is substantial equivalent to the Omnitech Resectoscope Cutting Loop Electrode (K981464) and the Cook Ireland Sonnet Polypectomy Snare (K050294) with respect to technical and design features. The submitted devices pos… | 1998 |
| * | K050294 | Cook Ireland Sonnet Polypectomy SnareSummary page 1…stantial Equivalence The LiNA Loop is substantial equivalent to the Omnitech Resectoscope Cutting Loop Electrode (K981464) and the Cook Ireland Sonnet Polypectomy Snare (K050294) with respect to technical and design features. The submitted devices pose the same type of questions about safety or effectivene… | 2005 |
What descends from it? (7)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 1, 2009 | Not classified | Z-2688-2011 | Labeling design | Potential for the LiNA Loop to break during operating procedure. |
| Dec 1, 2009 | Not classified | Z-2689-2011 | Labeling design | Potential for the LiNA Loop to break during operating procedure. |
| Dec 1, 2009 | Not classified | Z-2690-2011 | Labeling design | Potential for the LiNA Loop to break during operating procedure. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 19.7 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K111059 (Gyrus Acmi, Inc., 2011) has gone furthest, with 3 descendants of its own.
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. 2007, 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 Loop is a 5mm monopolar electrosurgical device intended for cutting 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/K070315 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070315: Lina Loop, Models: EL-160-4, EL-160-8, EL-200-4, EL-200-8.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070315
Report an extraction error
Are you the manufacturer?
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