510(k) · Cleared
ClearedManipulator; Manipulator Pro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gynetech Pty., Ltd. · LKF Cannula, Manipulator/Injector, Uterine
Cleared on Dec 17, 2014 as substantially equivalent to K071907 (Conmed Corporation, 2007) after a 133-day review. Its family tree reaches back 2 generations to 1996. 1 later device descends from it.
- Decided
- Dec 17, 2014
- Review
- 133 days
- Class
- Class II
- Product code
- LKF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K955446 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK955446 Conmed Vcare Retractor/ElevatorConmedcorp · 1996 · Recalled
- 1 generation backK071907 Vcare Retractor/ElevatorConmed Corporation · 2007 · Recalled
- This deviceK142164 Manipulator; Manipulator ProGynetech Pty., Ltd. · 2014
- Descendant · cites it directly · 0 of its ownK150519 ManipulatOR PRO, ManipulatORGynetech Pty., Ltd. · 2015
Most influential descendants
Showing 1 of 1 · See all- K150519ManipulatOR PRO, ManipulatORGynetech Pty., Ltd. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K955446 | Conmed Vcare Retractor/Elevator | Conmedcorp | 1996 | 3 |
| −1 | K071907 | Vcare Retractor/Elevator | Conmed Corporation | 2007 | 4 |
| 0 (this device) | K142164 | Manipulator; Manipulator Pro | Gynetech Pty., Ltd. | 2014 | — |
| +1 | K150519 | ManipulatOR PRO, ManipulatOR | Gynetech Pty., Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 LKF? 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 LKF device
- #1 K241693 FemChec Controlled Saline-Air Device (FCD-250)score 11.6 · 3 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 |
|---|---|---|---|
| * | K071907 | Vcare Retractor/ElevatorSummary page 4…evices: Primary Predicate Device: ConMed, VCare Vaginal-‐Cervical Ahluwalia’s Retractor-‐Elevator, K071907 Device Description: The ManipulatOR and ManipulatOR PRO are sterile, single-‐use… | 2007 |
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 |
|---|---|---|---|
| K150519 | ManipulatOR PRO, ManipulatOR | 2015 | 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?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 11.3 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K150519 (Gynetech Pty., Ltd., 2015) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K071907.
How does its category compare?
All LKF devicesLKF Cannula, Manipulator/Injector, Uterine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · LKF
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LKF
136in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LKF
3in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LKF
95in 2025
MAUDE reports naming product code LKF, 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 | 3 | 141 | 0 | 36 |
| 2008 | 0 | — | 2 | 59 |
| 2009 | 2 | — | 0 | 53 |
| 2010 | 6 | 178 | 0 | 46 |
| 2011 | 3 | 187 | 0 | 98 |
| 2012 | 0 | — | 2 | 104 |
| 2013 | 3 | 266 | 0 | 53 |
| 2014 | 3 | 169 | 0 | 45 |
| 2015 | 5 | 140 | 0 | 53 |
| 2016 | 1 | — | 0 | 62 |
| 2017 | 1 | — | 0 | 64 |
| 2018 | 4 | 267 | 0 | 23 |
| 2019 | 1 | — | 0 | 76 |
| 2020 | 0 | — | 0 | 119 |
| 2021 | 0 | — | 0 | 189 |
| 2022 | 4 | 79 | 3 | 100 |
| 2023 | 0 | — | 0 | 88 |
| 2024 | 3 | 136 | 0 | 125 |
| 2025 | 2 | — | 0 | 95 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ManipulatOR is indicated for manipulation of the uterus during laparoscopic procedures including laparoscopic assisted vaginal hysterectomy (LAVH), laparoscopic tubal occlusion, and diagnostic laparoscopy. The ManipulatOR, when used together with the McCartney Tube, is indicated for manipulation of the uterus during laparoscopic procedures requiring maintenance of pneumoperitoneum, such as total laparoscopic hysterectomy (TLH). The ManipulatOR PRO is…
Read the full statement (96 words)
The ManipulatOR is indicated for manipulation of the uterus during laparoscopic procedures including laparoscopic assisted vaginal hysterectomy (LAVH), laparoscopic tubal occlusion, and diagnostic laparoscopy. The ManipulatOR, when used together with the McCartney Tube, is indicated for manipulation of the uterus during laparoscopic procedures requiring maintenance of pneumoperitoneum, such as total laparoscopic hysterectomy (TLH).
The ManipulatOR PRO is indicated for manipulation of the uterus during laparoscopic procedures such as laparoscopic assisted vaginal hysterectomy (LAVH), total laparoscopic hysterectomy (TLH), laparoscopic tubal occlusion and diagnostic laparoscopy. The ManipulatOR PRO maintains pneumoperitoneum by sealing the vagina once colpotomy is performed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142164 · printed Nov 5, 2026
Cite this page
510(k) Report. “K142164: Manipulator; Manipulator Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K142164
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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