510(k) · Cleared
ClearedColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgitools Pty, Ltd. · HEW Culdoscope (And Accessories)
Cleared on Oct 27, 2016 as substantially equivalent to K110819 (J.Singh Instruments, 2011) after a 195-day review. Its family tree reaches back 2 generations to 1996.
- Decided
- Oct 27, 2016
- Review
- 195 days
- Class
- Class II
- Product code
- HEW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K954311 (1996). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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? (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 |
|---|---|---|---|
| * | K110819 | Singhmed Roolip ManipulatorSummary page 4…pulator/injector, uterine Device Class: Class II Classification Panel: Obstetrics/Gynecology 5. Legally Marketed Predicate Device(s) K110819, Singh Colpotomizer System, Surgitools Pty Ltd. 6. Device Description The Surgitools Pty Ltd. ColpoWave Colpotomizer and Cer… | 2011 |
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.
What does this lineage say?
- The line of descent spans 20 years and passes through 3 companies; a new generation was cleared every 14.9 years on median.
- 1 of the 2 ancestors has a recall of any class.
How does its category compare?
All HEW devicesHEW Culdoscope (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
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?
The ColpoWave Colpotomizer and CerviGrip Uterine Manipulator is indicated for use by a surgeon in laparoscopic procedures where uterine manipulation and visualization of the position of the vaginal fornices for colpotomy incisions is required, and for maintaining pneumoperitoneum during vaginal vault closure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161065 · printed Nov 4, 2026
Cite this page
510(k) Report. “K161065: ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K161065
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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