510(k) · Cleared
ClearedSymphion Operative Hysteroscopy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Minerva Surgical, Inc. · PGT Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar
Cleared on Jan 17, 2024 as substantially equivalent to K141848 (Iogyn, Inc., 2014) and 1 other predicate after a 58-day review. Its family tree reaches back 8 generations to 1996.
- Decided
- Jan 17, 2024
- Review
- 58 days
- Class
- Class II
- Product code
- PGT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K950035 (1996). 41 ancestors in all, the oldest K903419 (1990). No later device cites it as a predicate yet.
- Root · 8 generations backK950035 Surgiflator 20W.O.M. GmbH · 1996
- 7 generations backK955791 Surgiflator-20 PimW.O.M. World of Medicine GmbH · 1996
- 6 generations backK981859 Surgiflator-20 EcuW.O.M. World of Medicine GmbH · 1998
- 5 generations backK990443 Arthro-Surgimat-2000 EcuW.O.M. World of Medicine GmbH · 1999
- 4 generations backK030402 Arthroscopy Pump, Model A107W.O.M. World of Medicine AG · 2003
- 3 generations backK062380 Flosimple Arthroscopy Pump A120W.O.M. World of Medicine AG · 2006 · Recalled
- 2 generations backK112642 Aquilex Fluid Control System H112W.O.M. World of Medicine AG · 2012
- 1 generation backK180825 Fluent Fluid Management SystemHologic, Inc. · 2018
- This deviceK233710 Symphion Operative Hysteroscopy SystemMinerva Surgical, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K950035 | Surgiflator 20 | W.O.M. GmbH | 1996 | — |
| −7 | K955791 | Surgiflator-20 Pim | W.O.M. World of Medicine GmbH | 1996 | — |
| −6 | K981859 | Surgiflator-20 Ecu | W.O.M. World of Medicine GmbH | 1998 | — |
| −5 | K990443 | Arthro-Surgimat-2000 Ecu | W.O.M. World of Medicine GmbH | 1999 | — |
| −4 | K030402 | Arthroscopy Pump, Model A107 | W.O.M. World of Medicine AG | 2003 | — |
| −3 | K062380 | Flosimple Arthroscopy Pump A120 | W.O.M. World of Medicine AG | 2006 | 1 |
| −2 | K112642 | Aquilex Fluid Control System H112 | W.O.M. World of Medicine AG | 2012 | — |
| −1 | K180825 | Fluent Fluid Management System | Hologic, Inc. | 2018 | — |
| 0 (this device) | K233710 | Symphion Operative Hysteroscopy System | Minerva Surgical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 5 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2017 | 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 PGT? 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 |
|---|---|---|---|
| * | K141848 | Iogyn SystemSummary page 5…Predicate (Secondary) Trade Name IOGYN System Fluent® Fluid Management System 510(k) # K141848 (originally cleared through DeNovo K180825 K132695) 510(k) Applicant IOGYN, Inc… | 2014 |
| * | K180825 | Fluent Fluid Management SystemSummary page 5…Trade Name IOGYN System Fluent® Fluid Management System 510(k) # K141848 (originally cleared through DeNovo K180825 K132695) 510(k) Applicant IOGYN, Inc HOLOGIC, INC.… | 2018 |
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 28 years and passes through 5 companies; a new generation was cleared every 4.1 years on median.
- 5 of the 41 ancestors have a recall of any class.
How does its category compare?
All PGT devicesPGT Insufflator, Hysteroscopic, Fluid, Closed-Loop Recirculation With Cutter-Coagulator, Endoscopic, Bipolar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · PGT
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PGT
Too few PGT 510(k)s in any year since 2007 to give a median.
Recalls per year · PGT
No recall names PGT since 2007.
Adverse event reports per year · PGT
1in 2025
MAUDE reports naming product code PGT, 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 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 7 |
| 2016 | 0 | — | 0 | 19 |
| 2017 | 0 | — | 0 | 39 |
| 2018 | 0 | — | 0 | 17 |
| 2019 | 0 | — | 0 | 13 |
| 2020 | 0 | — | 0 | 7 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 5 |
| 2024 | 1 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Symphion Operative Hysteroscopy System and accessories are intended for resection and coagulation of uterine tissue such as intrauterine polyps and myomas using a bipolar resecting device by distending the uterus with saline to facilitate viewing with a hysteroscope during diagnostic and operative hysteroscopy and providing fluid management through either the closed loop recirculation of filtered distension fluid or non-recirculating/non-filtered distension fluid.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233710 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233710: Symphion Operative Hysteroscopy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233710
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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