# K964276: Endoscopic Hysterectomy and Uterus Manipulator

- Pathway: 510(k) (Traditional)
- Applicant: Richard Wolf Medical Instruments Corp.
- Decided: Nov 25, 1997 after 393 days
- Product code: HEW (Culdoscope (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Valtchev manipulator: named in the summary without a submission number
- (no number) RUMI: named in the summary without a submission number
- (no number) 8370.00: named in the summary without a submission number
- (no number) 26201A: named in the summary without a submission number
- (no number) 24945A: named in the summary without a submission number
- (no number) 8991.02: named in the summary without a submission number
- (no number) 74837 C: named in the summary without a submission number
- (no number) 24945A0: named in the summary without a submission number
- (no number) 24945E: named in the summary without a submission number

## Indications for use
For laparoscopic assisted vaginal hysterectomy. The Endoscopic Hysterectomy instrument set consisting of vaginal tube, mandrin and instrumentation insert is used to support LAVH (laparoscopically assisted vaginal hysterectomy). The tube is used for visualization of the cervical portio. The distal section of the vaginal tube can be seen during laparoscopically assisted vaginal hysterectomy, and thus serves the surgeon as a guide and support during cutting. The tube allows pneumoperitoneum to be maintained during cutting and opening of the posterior vaginal vault. The mandrin supports the introduction of the tube into the vagina. Prior to introduction it is inserted into the vaginal tube and locked in place. The instrumentation insert has two openings - instrument ports - through which surgical instruments are inserted into the vaginal tube without loss of gas. Indication: For the use of the uterus manipulator in endoscopic hysterectomy: • Uterus myomatosis • Abnormal uterine bleeding The Uterus Manipulator set, consisting of uterus manipulator and uterus probe is used to support LAVH. The uterus manipulator is an instrument with a distally inclinable probe section. The part of the instrument which is inserted in the uterus serves to fix the uterus and change or manipulate its position.

Source page: https://510kreport.com/device/K964276
Methodology: https://510kreport.com/methodology