510(k) · Cleared
ClearedLaparette
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rd Chus, Inc. · KNF Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Cleared on Aug 25, 1997 as substantially equivalent to K921696 (American Cyanamid Co., 1992) and 1 other predicate after a 150-day review. Its family tree reaches back 1 generation to 1991. 1 later device descends from it.
- Decided
- Aug 25, 1997
- Review
- 150 days
- Class
- Class II
- Product code
- KNF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K912492 (1991). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K022979Laparette, Model Lap J L S H NInstruments Medicaux G.B., Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K912492 | Evacuation/Irrigation/Elecrosurgical Device | ETHICON, Inc. | 1991 | 22 |
| 0 (this device) | K971146 | Laparette | Rd Chus, Inc. | 1997 | — |
| +1 | K022979 | Laparette, Model Lap J L S H N | Instruments Medicaux G.B., Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 |
|---|---|---|---|
| * | K921696 | Cutting and Coagulation Devices and AccessoriesSummary page 1…aparoscopic accessory 5. IDENTIFICATION OF THE PREDICATE OR LEGALLY MARKETED DEVICE(S) TO WHICH EQUIVALENCE IS BEING CLAIMED: Davis+ Geck’s Multi-Function Pistol Grip (K921696) American Cyanamid Co. Ethicon Endopath Probe Plus (K912492) Ethicon, Inc. 6. DEVICE DESCRIPTION: INTENDED USE: The LAPARETTE… | 1992 |
| * | K912492 | Evacuation/Irrigation/Elecrosurgical DeviceSummary page 1…LEGALLY MARKETED DEVICE(S) TO WHICH EQUIVALENCE IS BEING CLAIMED: Davis+ Geck’s Multi-Function Pistol Grip (K921696) American Cyanamid Co. Ethicon Endopath Probe Plus (K912492) Ethicon, Inc. 6. DEVICE DESCRIPTION: INTENDED USE: The LAPARETTE is intended for use in minimally invasive surgery, including… | 1991 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K022979 | Laparette, Model Lap J L S H N | 2002 | 0 |
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?
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K022979 (Instruments Medicaux G.B., Inc., 2002) has gone furthest, with 0 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.
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 LAPARETTE is an electrosurgical instrument with integral suction and irrigation capability It is intended for use in minimally invasive surgery, including laparoscopy, to cut tissue and control bleeding by use of high frequency electrical current, to irrigate tissue and cavities, as well as to suction fluids from the wound. This device is not intended for use in tubal sterilization procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971146 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971146: Laparette.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971146
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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