510(k) · Cleared
ClearedGelPOINT V-Path Vaginal Access System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Medical Resources Corporation · MOK Vaginoscope And Accessories
Cleared on Sep 16, 2022 as substantially equivalent to K950639 (KARL STORZ Endoscopy-America, Inc., 1995) after a 165-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Sep 16, 2022
- Review
- 165 days
- Class
- Class II
- Product code
- MOK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K950639 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK950639 Karl Storz Infant, Balloon Vaginoscope, Vaginoscope Sheath, Fiber…KARL STORZ Endoscopy-America, Inc. · 1995
- This deviceK220969 GelPOINT V-Path Vaginal Access SystemApplied Medical Resources Corporation · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K950639 | Karl Storz Infant, Balloon Vaginoscope, Vaginoscope Sheath, Fiber Optic Light… | KARL STORZ Endoscopy-America, Inc. | 1995 | — |
| 0 (this device) | K220969 | GelPOINT V-Path Vaginal Access System | Applied Medical Resources Corporation | 2022 | — |
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 MOK? 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? (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 |
|---|---|---|---|
| * | K950639 | Karl Storz Infant, Balloon Vaginoscope, Vaginoscope Sheath, Fiber Optic Light Carriers…Summary page 4…Code: MOK, Vaginoscope and accessories Predicate Device: Trade Name: KARL STORZ INFANT, BALLOON VAGINOSCOPE 510(k) #: K950639 Product Code: MOK Through FDA database search following predicate device has… | 1995 |
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 MOK devicesMOK Vaginoscope And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · MOK
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · MOK
Too few MOK 510(k)s in any year since 2007 to give a median.
Recalls per year · MOK
No recall names MOK since 2007.
Adverse event reports per year · MOK
1in 2020
MAUDE reports naming product code MOK, 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 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The GelPOINT V-Path Vaginal Access System (VAS) is intended to be inserted in the vagina to allow for entry of minimally invasive instruments while maintaining insufflation for vaginal gynecological procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220969 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220969: GelPOINT V-Path Vaginal Access System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220969
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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