510(k) · Cleared
ClearedCook Word Bartholin Gland Catheter (Final Trade Name Not Yet Determined)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Urological, Inc. · KNA Instrument, Manual, Specialized Obstetric-Gynecologic
Cleared on May 6, 2011 as substantially equivalent to K861385 (Milex Products, Inc., 1986) and 1 other predicate after a 281-day review. Its family tree reaches back 1 generation to 1986.
- Decided
- May 6, 2011
- Review
- 281 days
- Class
- Class II
- Product code
- KNA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K861385 (1986). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK861385 Milex Bartholin Gland CatheterMilex Products, Inc. · 1986
- This deviceK102141 Cook Word Bartholin Gland Catheter (Final Trade Name Not Yet…Cook Urological, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K861385 | Milex Bartholin Gland Catheter | Milex Products, Inc. | 1986 | — |
| 0 (this device) | K102141 | Cook Word Bartholin Gland Catheter (Final Trade Name Not Yet Determined) | Cook Urological, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 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 KNA? 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 |
|---|---|---|---|
| * | K861385 | Milex Bartholin Gland CatheterSummary page 1…28 days to allow the duct to re-epithelialize. The devices are provided sterile and are intended for one time use. Predicate Devices: 510(k) number: K861385 Current Trade Name: Word Bartholin Gland Catheter for Cyst and Abscess Drainage Distributed by:… | 1986 |
| * | K880497 | Word Bartholin Gland Catheter Code: 1005Summary page 2…CooperSurgical Incorporated 510(k) Applicant: Milex Products Incorporated 5.10(k) number: K880497 Current Trade Name: Word Bartholin Catheter Distributed by: Rusch Medic… | 1988 |
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All KNA devicesKNA Instrument, Manual, Specialized Obstetric-Gynecologic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · KNA
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · KNA
Too few KNA 510(k)s in any year since 2007 to give a median.
Recalls per year · KNA
No recall names KNA since 2007.
Adverse event reports per year · KNA
5in 2025
MAUDE reports naming product code KNA, 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 | 2 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 8 |
| 2011 | 1 | — | 0 | 13 |
| 2012 | 0 | — | 0 | 8 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 4 |
| 2015 | 0 | — | 0 | 8 |
| 2016 | 0 | — | 0 | 22 |
| 2017 | 0 | — | 0 | 37 |
| 2018 | 0 | — | 0 | 63 |
| 2019 | 0 | — | 0 | 5 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Used for the treatment of abscesses and cysts of the Bartholin gland.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102141 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102141: Cook Word Bartholin Gland Catheter (Final Trade Name Not Yet Determined).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102141
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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