# K102141: Cook Word Bartholin Gland Catheter (Final Trade Name Not Yet Determined)

- Pathway: 510(k) (Traditional)
- Applicant: Cook Urological, Inc.
- Decided: May 6, 2011 after 281 days
- Product code: KNA (Instrument, Manual, Specialized Obstetric-Gynecologic)
- Device class: 2
- Regulation: 21 CFR 884.4530
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K861385 (1986). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K861385: Milex Bartholin Gland Catheter, Milex Products, Inc. (1986) Summary page 1.
- K880497: Word Bartholin Gland Catheter Code: 1005, Hoosier Specialties, Inc. (1988) Summary page 2.

## Indications for use
Used for the treatment of abscesses and cysts of the Bartholin gland.

Source page: https://510kreport.com/device/K102141
Methodology: https://510kreport.com/methodology