# K071405: Probe Holder System

- Pathway: 510(k) (Traditional)
- Applicant: Intuitive Surgical, Inc.
- Decided: Oct 9, 2007 after 141 days
- Product code: LKF (Cannula, Manipulator/Injector, Uterine)
- Device class: 2
- Regulation: 21 CFR 884.4530
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K941458 (1995). 2 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033644: Endoboy, Geyser S.A. (2004) Summary page 2.
- K941458: Uterine Manipulator/Injector with Spring, Zinnanti Surgical Instruments, Inc. (1995) Summary page 2.
- (no number) Mediflex Flex Arm: named in the summary without a submission number
- (no number) Thompson Retractor/Device Holder: named in the summary without a submission number

## Most influential descendants
- K141523: Ally Ups (2014), 2 descendants of its own
- K223064: ALLY II Uterine Positioning System™ (UPS) (2022), 0 descendants of its own
- K153092: Ally Uterine Positioning System (2015), 0 descendants of its own
- K130758: Kronner Side-Kick Uterine Manipulator Holder (2013), 0 descendants of its own
- K122820: Viky UP (2013), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K071405
Methodology: https://510kreport.com/methodology
