510(k) · Cleared
ClearedGinram Endocic Single Oval Port (Model NO. 720195)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ri Mos. S.R.L. · HHK Curette, Suction, Endometrial (And Accessories)
Cleared on Oct 26, 1999 as substantially equivalent to K991895 (Ri Mos. S.R.L., 1999) after a 56-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Oct 26, 1999
- Review
- 56 days
- Class
- Class II
- Product code
- HHK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K991895 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK991895 Rampipella, Singe Port (720196) & Wedge-Shaped Port (720217)Ri Mos. S.R.L. · 1999
- This deviceK992926 Ginram Endocic Single Oval Port (Model NO. 720195)Ri Mos. S.R.L. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K991895 | Rampipella, Singe Port (720196) & Wedge-Shaped Port (720217) | Ri Mos. S.R.L. | 1999 | — |
| 0 (this device) | K992926 | Ginram Endocic Single Oval Port (Model NO. 720195) | Ri Mos. S.R.L. | 1999 | — |
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 HHK? 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 HHK device
- #1 K251882 Uterine Aspiration Setscore 10.5 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K991895 | Rampipella, Singe Port (720196) & Wedge-Shaped Port (720217)Summary page 1…s curette, and the classification name is Endometrial suction curette. 3. The above device is substantially equivalent to the RI. MOS. s.r.l. device GINRAM® Rampipella, K991895, clearance date August 12, 1999. 4. The RT MOS. s.r.l. curette operates manually by applied vacuum sucitlion and 1s a sterile si… | 1999 |
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?
- Its one ancestor has no recall.
How does its category compare?
All HHK devicesHHK Curette, Suction, Endometrial (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HHK
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HHK
Too few HHK 510(k)s in any year since 2007 to give a median.
Recalls per year · HHK
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HHK
9in 2025
MAUDE reports naming product code HHK, 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 | 2 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 2 | 0 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 1 | 2 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 4 |
| 2025 | 1 | — | 0 | 9 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
For endometrial sampling for histologic biopsy of the uterine mucosal lining including post menopausal patients.
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/K992926 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992926: Ginram Endocic Single Oval Port (Model NO. 720195).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992926
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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