510(k) · Cleared
ClearedEndoscopic Hysterectomy and Uterus Manipulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Richard Wolf Medical Instruments Corp. · HEW Culdoscope (And Accessories)
Cleared on Nov 25, 1997 after a 393-day review. The FDA summary names its predicate without a number.
- Decided
- Nov 25, 1997
- Review
- 393 days
- Class
- Class II
- Product code
- HEW
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 HEW? 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 HEW device
- #1 K243152 GelPOINT V-Path Transvaginal Access Platform…score 11.0 · 4 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (9)
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 |
|---|---|---|---|
| * | — | Valtchev manipulator Named without a submission number | |
| * | — | RUMI Named without a submission number | |
| * | — | 8370.00 Named without a submission number | |
| * | — | 26201A Named without a submission number | |
| * | — | 24945A Named without a submission number | |
| * | — | 8991.02 Named without a submission number | |
| * | — | 74837 C Named without a submission number | |
| * | — | 24945A0 Named without a submission number | |
| * | — | 24945E Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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.
How does its category compare?
All HEW devicesHEW Culdoscope (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HEW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HEW
Too few HEW 510(k)s in any year since 2007 to give a median.
Recalls per year · HEW
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HEW
20in 2025
MAUDE reports naming product code HEW, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 1 | — | 0 | 3 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 3 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 9 |
| 2017 | 0 | — | 0 | 15 |
| 2018 | 1 | — | 1 | 14 |
| 2019 | 1 | — | 0 | 29 |
| 2020 | 1 | — | 0 | 35 |
| 2021 | 0 | — | 0 | 14 |
| 2022 | 0 | — | 0 | 23 |
| 2023 | 0 | — | 0 | 18 |
| 2024 | 0 | — | 0 | 32 |
| 2025 | 1 | — | 0 | 20 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (197 words)
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.
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/K964276 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964276: Endoscopic Hysterectomy and Uterus Manipulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964276
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026