510(k) · Cleared
ClearedTransvaginal Endoscopy Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KARL STORZ Endoscopy-America, Inc. · HEW Culdoscope (And Accessories)
Cleared on Feb 27, 2004 after a 91-day review. The FDA summary names no predicate by number.
- Decided
- Feb 27, 2004
- Review
- 91 days
- Class
- Class II
- Product code
- HEW
- Recalls
- None
- Predicates
- 0
The FDA summary names no predicate by number.
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?
The FDA summary names no predicate by number.
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.
How does its category compare?
All HEW devicesHEW Culdoscope (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
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 TVE Set is indicated for use by qualified surgeons during outpatient or clinical endoscopic examination of the female genital tract. This examination method is designed to provide video visual access for endoscopic examination of the vagina, cervix and uterus, and through transvaginal access, illow visualization of both fallopian tubes and the ovaries to perform diagnostic and operative procedures. Indications for use are: * Unexplained pelvic pain…
Read the full statement (113 words)
The TVE Set is indicated for use by qualified surgeons during outpatient or clinical endoscopic examination of the female genital tract. This examination method is designed to provide video visual access for endoscopic examination of the vagina, cervix and uterus, and through transvaginal access, illow visualization of both fallopian tubes and the ovaries to perform diagnostic and operative procedures. Indications for use are:
* Unexplained pelvic pain (acute, chronic)
* Menstrual abnormalities;
* Infertility and sterility;
* Indefinite pelvic mass;
* Ectopic pregnancy;
* Pelvic endometriosis;
* Polycystic ovaries;
* Pelvic inflammatory disease (PID);
* Pain mapping;
* Congenital abnormalities of the pelvic organs;
* Lysis of adhesions;
* Cytology mapping;
* Biopsy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033728 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033728: Transvaginal Endoscopy Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033728
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026