510(k) · Cleared
ClearedRigid Culdoscope and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Circon Corp. · HEW Culdoscope (And Accessories)
Cleared on Jun 12, 1998 after an 88-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Jun 12, 1998
- Review
- 88 days
- Class
- Class II
- Product code
- HEW
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK980972 Rigid Culdoscope and AccessoriesCircon Corp. · 1998
- Descendant · cites it directly · 0 of its ownK992544 Transvaginal Hydro Laparoscopy (THL) SystemCircon Corp. · 1999
Most influential descendants
Showing 1 of 1 · See all- K992544Transvaginal Hydro Laparoscopy (THL) SystemCircon Corp. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K980972 | Rigid Culdoscope and Accessories | Circon Corp. | 1998 | — |
| +1 | K992544 | Transvaginal Hydro Laparoscopy (THL) System | Circon Corp. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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 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? (4)
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 |
|---|---|---|---|
| * | — | ACMI’s Decker Culdoscope Named without a submission number | |
| * | — | ACMI’s Decker Operating Culdoscope Named without a submission number | |
| * | — | Karl Storz Endoscopy America, Inc.’s Culdoscopes Named without a submission number | |
| * | — | Richard Wolf Medical Instrument Corp.’s Fiber Light Culdoscopes Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K992544 | Transvaginal Hydro Laparoscopy (THL) System | 1999 | 0 |
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?
- Of its descendants, K992544 (Circon Corp., 1999) has gone furthest, with 0 descendants of its own.
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?
Circon’s Rigid Culdoscopes and Accessories are intended for viewing pelvic oigans endoscopically via a posterior vaginal fornix entry. Culdoscopy is indicated for:
Unexplained pelvic pain (acute, chronic)
Menstrual abnormalities
Infertility and sterility
Indefinite pelvic mass
Ectopic pregnancy
Pelvic endometriosis
Polycystic ovaries
Pelvic inflammatory disease
Pain mapping
Congenital anomalies of the pelvic organs
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/K980972 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980972: Rigid Culdoscope and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980972
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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