510(k) · Cleared
ClearedProbe Holder System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intuitive Surgical, Inc. · LKF Cannula, Manipulator/Injector, Uterine
Cleared on Oct 9, 2007 as substantially equivalent to K033644 (Geyser S.A., 2004) and 1 other predicate after a 141-day review. Its family tree reaches back 1 generation to 1995. 5 later devices descend from it.
- Decided
- Oct 9, 2007
- Review
- 141 days
- Class
- Class II
- Product code
- LKF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K941458 (1995). 2 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK941458 Uterine Manipulator/Injector with SpringZinnanti Surgical Instruments, Inc. · 1995
- This deviceK071405 Probe Holder SystemIntuitive Surgical, Inc. · 2007
- Descendant · cites it directly · 2 of its ownK141523 Ally UpsCooperSurgical, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 0 of its ownK223064 ALLY II Uterine Positioning System™ (UPS)CooperSurgical, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK153092 Ally Uterine Positioning SystemCooperSurgical, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK130758 Kronner Side-Kick Uterine Manipulator HolderKronner Prototypes, Inc. · 2013
- Descendant · cites it directly · 0 of its ownK122820 Viky UPEndocontrol · 2013
Most influential descendants
Showing 5 of 5 · See all- K141523Ally UpsCooperSurgical, Inc. · 2014 · cites it directly2descendants
- K223064ALLY II Uterine Positioning System™ (UPS)CooperSurgical, Inc. · 2022 · 2 generations on0descendants
- K153092Ally Uterine Positioning SystemCooperSurgical, Inc. · 2015 · 2 generations on0descendants
- K130758Kronner Side-Kick Uterine Manipulator HolderKronner Prototypes, Inc. · 2013 · cites it directly0descendants
- K122820Viky UPEndocontrol · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K941458 | Uterine Manipulator/Injector with Spring | Zinnanti Surgical Instruments, Inc. | 1995 | — |
| 0 (this device) | K071405 | Probe Holder System | Intuitive Surgical, Inc. | 2007 | — |
| +1 | K141523 | Ally Ups | CooperSurgical, Inc. | 2014 | 1 |
| +2 | K223064 | ALLY II Uterine Positioning System™ (UPS) | CooperSurgical, Inc. | 2022 | — |
| +2 | K153092 | Ally Uterine Positioning System | CooperSurgical, Inc. | 2015 | — |
| +1 | K130758 | Kronner Side-Kick Uterine Manipulator Holder | Kronner Prototypes, Inc. | 2013 | — |
| +1 | K122820 | Viky UP | Endocontrol | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2022 | 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? (4)
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 |
|---|---|---|---|
| * | K033644 | EndoboySummary page 2…f 3 Page 9 of 78 Predicate Endoboy (K033644) Devices Geyser, SA Zinnanti Uterine Manipulator/Injector (K941458)… | 2004 |
| * | K941458 | Uterine Manipulator/Injector with SpringSummary page 2…e 9 of 78 Predicate Endoboy (K033644) Devices Geyser, SA Zinnanti Uterine Manipulator/Injector (K941458) Zinnanti Surgical Devices, Chatsworth, CA Mediflex Flex Arm (Pre-ame… | 1995 |
| * | — | Mediflex Flex Arm Named without a submission number | |
| * | — | Thompson Retractor/Device Holder Named without a submission number |
What descends from it? (5)
3 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
- Of its descendants, K141523 (CooperSurgical, Inc., 2014) has gone furthest, with 2 descendants of its own.
How does its category compare?
All LKF devicesLKF Cannula, Manipulator/Injector, Uterine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Probe Holder System is intended to assist the surgical staff in mounting, positioning and holding a uterine manipulator during gynecological laparoscopic surgical procedures. It is intended for use by trained operating room personnel in an operating room environment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071405 · printed Nov 5, 2026
Cite this page
510(k) Report. “K071405: Probe Holder System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071405
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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