510(k) · Cleared
ClearedTransvaginal Hydro Laparoscopy (THL) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Circon Corp. · HEX Colposcope (And Colpomicroscope)
Cleared on Oct 26, 1999 as substantially equivalent to K980972 (Circon Corp., 1998) after an 88-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Oct 26, 1999
- Review
- 88 days
- Class
- Class II
- Product code
- HEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K980972 (1998). No later device cites it as a predicate yet.
- Root · 1 generation backK980972 Rigid Culdoscope and AccessoriesCircon Corp. · 1998
- This deviceK992544 Transvaginal Hydro Laparoscopy (THL) SystemCircon Corp. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K980972 | Rigid Culdoscope and Accessories | Circon Corp. | 1998 | — |
| 0 (this device) | K992544 | Transvaginal Hydro Laparoscopy (THL) System | Circon Corp. | 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 HEX? 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 HEX device
- #1 K233043 Smart Scope® CXscore 8.4 · 4 generations · no Class I recall
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 |
|---|---|---|---|
| * | K980972 | Rigid Culdoscope and AccessoriesSummary page 1…cessories. The Decker devices were legally marketed for the same intended use (i.e., culdoscopy) prior to May 28, 1976, and the Circon devices were cleared under 510(k) #K980972 on June 12, 1998. Description of Device: Circon’s Rigid Operative Culdoscopy Accessories consist of several tubular stainless s… | 1998 |
| * | — | ACMI Decker Operating Culdoscope and accessories Named without a submission 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.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All HEX devicesHEX Colposcope (And Colpomicroscope): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HEX
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HEX
165in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HEX
No recall names HEX since 2007.
Adverse event reports per year · HEX
1in 2025
MAUDE reports naming product code HEX, 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 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 3 | 129 | 0 | 0 |
| 2011 | 2 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 3 | 211 | 0 | 2 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 3 | 165 | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Circon’s Rigid Operative Culdoscopy Accessories are intended to be used with Circon’s Rigid Culdoscope and Accessories for viewing pelvic organs endoscopically via a posterior vaginal fornix entry for the purpose of performing diagnostic and operative procedures on the female genital organs.
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 anomalies of the pelvic organs
Lysis of adhesions
Cytology sampling
Biopsy
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/K992544 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992544: Transvaginal Hydro Laparoscopy (THL) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992544
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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