510(k) · Cleared
ClearedManipuseal
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Insitu Systems · HEW Culdoscope (And Accessories)
Cleared on Sep 2, 2005 as substantially equivalent to K010056 (A & A Medical, Inc., 2001) and 1 other predicate after a 120-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Sep 2, 2005
- Review
- 120 days
- Class
- Class II
- Product code
- HEW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K954311 (1996). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK954311 Koh Colpotomizer SystemCooperSurgical, Inc. · 1996 · Recalled
- This deviceK051160 ManipusealInsitu Systems · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954311 | Koh Colpotomizer System | CooperSurgical, Inc. | 1996 | 2 |
| 0 (this device) | K051160 | Manipuseal | Insitu Systems | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 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? (2)
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 |
|---|---|---|---|
| * | K010056 | Uterine Manipulator Injector Cannula, Sterile, Model R 57-450Summary page 1…assification Name: Uterine Manipulator/Injector and Accessories 3. PRED ICATE DEVICES A & A Medical Uterine Manipulator K010056 RUMI Koh Colpotomizer System Manipulator/Occluder K9543 11 4. DEVICE DESCRIPTION The Mani… | 2001 |
| * | K954311 | Koh Colpotomizer SystemSummary page 1…PRED ICATE DEVICES A & A Medical Uterine Manipulator K010056 RUMI Koh Colpotomizer System Manipulator/Occluder K9543 11 4. DEVICE DESCRIPTION The Manipuseal device is comprised of an occluding balloon, Manipuseal uterine… | 1996 |
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?
- 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.
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 Manipuseal device is indicated for use in all laparoscopic surgical procedures where use of a uterine manipulator is appropriate and the surgeon intends to remove intraperitoneal tissue through the vagina by use of a colpotomy or culdotomy incision.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051160 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051160: Manipuseal.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051160
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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