510(k) · Cleared
ClearedSinghmed Roolip Manipulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
J.Singh Instruments · HEW Culdoscope (And Accessories)
Cleared on Oct 5, 2011 as substantially equivalent to K954311 (CooperSurgical, Inc., 1996) after a 196-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it.
- Decided
- Oct 5, 2011
- Review
- 196 days
- Class
- Class II
- Product code
- HEW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954311 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK954311 Koh Colpotomizer SystemCooperSurgical, Inc. · 1996 · Recalled
- This deviceK110819 Singhmed Roolip ManipulatorJ.Singh Instruments · 2011
- Descendant · cites it directly · 0 of its ownK161065 ColpoWave™ Colpotomizer and CerviGrip™ Uterine ManipulatorSurgitools Pty, Ltd. · 2016
Most influential descendants
Showing 1 of 1 · See all- K161065ColpoWave™ Colpotomizer and CerviGrip™ Uterine ManipulatorSurgitools Pty, Ltd. · 2016 · cites it directly0descendants
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) | K110819 | Singhmed Roolip Manipulator | J.Singh Instruments | 2011 | — |
| +1 | K161065 | ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator | Surgitools Pty, Ltd. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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? (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 |
|---|---|---|---|
| * | K954311 | Koh Colpotomizer SystemSummary page 1…ories) 884.1640, HEW Device Class: 2 Legally Marketed Devices to which Substantial Equivalence is Claimed: The Koh Colpotomizer System 510(k) Number: K954311 CooperSurgical, Inc intended Use: The Singh Colpotomizer System is indicated for use by a surgeon in laparoscopic procedures whe… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161065 | ColpoWave™ Colpotomizer and CerviGrip™ Uterine Manipulator | 2016 | 0 |
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?
How does its category compare?
All HEW devicesHEW Culdoscope (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Singh Colpotomizer System 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. The surgeon makes the colpotomy incisions to access or remove intraperitoneal tissue.
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/K110819 · printed Nov 5, 2026
Cite this page
510(k) Report. “K110819: Singhmed Roolip Manipulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K110819
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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