510(k) · Cleared
ClearedRigid Cannulae Curved (RC6-RC12), Rigid Cannulae Straight (RS6-RS12)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Womancare Global · HGH Cannula, Suction, Uterine
Cleared on Mar 4, 2010 as substantially equivalent to K030935 (Acmi Corporation, 2003) and 1 other predicate after a 112-day review. Its family tree reaches back 2 generations to 1981. 2 later devices descend from it.
- Decided
- Mar 4, 2010
- Review
- 112 days
- Class
- Class II
- Product code
- HGH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K813282 (1981). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK813282 Synevac Vacuum Curettage SystemsSynemed, Inc. · 1981
- 1 generation backK030935 Berkeley V-10 Vacuum Curettage SystemAcmi Corporation · 2003 · Recalled
- This deviceK093508 Rigid Cannulae Curved (RC6-RC12), Rigid Cannulae Straight (RS6-RS12)Womancare Global · 2010
- Descendant · cites it directly · 1 of its ownK140213 Disposable Endoscopic CannulaDongguan Microview Medical Technology Co., Ltd. · 2015
- Descendant · 2 generations on · 0 of its ownK172151 Hysteroscopy SystemChongquin Jinshan Science & Technology (Group) Co., Ltd. · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K813282 | Synevac Vacuum Curettage Systems | Synemed, Inc. | 1981 | — |
| −1 | K030935 | Berkeley V-10 Vacuum Curettage System | Acmi Corporation | 2003 | 1 |
| 0 (this device) | K093508 | Rigid Cannulae Curved (RC6-RC12), Rigid Cannulae Straight (RS6-RS12) | Womancare Global | 2010 | — |
| +1 | K140213 | Disposable Endoscopic Cannula | Dongguan Microview Medical Technology Co., Ltd. | 2015 | — |
| +2 | K172151 | Hysteroscopy System | Chongquin Jinshan Science & Technology (Group) Co., Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 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 HGH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K030935 | Berkeley V-10 Vacuum Curettage SystemSummary page 1…Class 11device Establishment Registration Number: 3008007615 Identification of Substantially Equivalent Device: Berkeley VCl 0-Vacuum Curettage System and Accessories (K030935) and Synevac Vacuum Curettage System 10 (K813282). These 510O(k) applications include vacuum pumps as well as the uterine suction… | 2003 |
| * | K813282 | Synevac Vacuum Curettage SystemsSummary page 1…: 3008007615 Identification of Substantially Equivalent Device: Berkeley VCl 0-Vacuum Curettage System and Accessories (K030935) and Synevac Vacuum Curettage System 10 (K813282). These 510O(k) applications include vacuum pumps as well as the uterine suction cannulae and accessories. Description of Device… | 1981 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140213 | Disposable Endoscopic Cannula | 2015 | 1 |
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 29 years and passes through 3 companies; a new generation was cleared every 21.5 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K140213 (Dongguan Microview Medical Technology Co., Ltd., 2015) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K030935.
How does its category compare?
All HGH devicesHGH Cannula, Suction, Uterine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · HGH
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · HGH
Too few HGH 510(k)s in any year since 2007 to give a median.
Recalls per year · HGH
No recall names HGH since 2007.
Adverse event reports per year · HGH
1in 2024
MAUDE reports naming product code HGH, 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 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For rapid transcervical aspiration of the uterine cavity during the first trimester of pregnancy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093508 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093508: Rigid Cannulae Curved (RC6-RC12), Rigid Cannulae Straight (RS6-RS12).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093508
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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