Panpac Word/Bartholin Catheter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K130087 FDA 510(k)
- FDA Product Code
- KNA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.4530 FDA 510(k)
- Regulation Number
- 884.4530 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The WC-400 Word/Bartholin Catheter is a manual, specialized obstetric-gynecologic instrument classified as a Class II device. It is designed for the drainage and treatment of Bartholin gland abscesses and cysts by facilitating ductal patency through controlled insertion and inflation.
This silicone, latex-free catheter is supplied as a sterile, single-use device for clinical use in obstetrics and gynecology. It is intended for insertion by a clinician to relieve obstruction and maintain drainage in Bartholin gland ducts. The device complies with FDA 510(k) clearance (K130087) under regulatory classification KNA, ensuring adherence to medical specialty standards for obstetric-gynecologic procedures.
Frequently asked questions
What is the WC-400 Word/Bartholin Catheter used for?
The WC-400 Word/Bartholin Catheter is designed specifically for the drainage and treatment of Bartholin gland abscesses and cysts. It works by facilitating ductal patency through controlled insertion and inflation, helping to relieve obstruction and maintain continuous drainage in the Bartholin gland ducts.
Is the WC-400 Word/Bartholin Catheter reusable or single-use?
The WC-400 Word/Bartholin Catheter is supplied as a sterile, single-use device. This ensures patient safety by preventing cross-contamination and maintaining sterility for each clinical procedure.
What material is the WC-400 Word/Bartholin Catheter made from?
The catheter is made from silicone and is latex-free, which reduces the risk of allergic reactions in patients who may be sensitive to latex or other materials.
How is the WC-400 Word/Bartholin Catheter supplied?
The WC-400 Word/Bartholin Catheter is supplied sterile and ready for immediate clinical use. It is packaged to maintain sterility until opened, ensuring it is safe for single-use in obstetrics and gynecology procedures.
What regulatory clearance does the WC-400 Word/Bartholin Catheter hold?
The WC-400 Word/Bartholin Catheter holds FDA 510(k) clearance under the product code KNA, with a clearance number of K130087. This clearance confirms it meets regulatory standards for specialized obstetric-gynecologic instruments.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Word/Bartholin Catheter - Panpac Medical - PDF Catalogs | Technical ..., PANPAC WORD/BARTHOLIN CATHETER (K130087) — FDA 510 (k) | Innolitics, HSG Catheter Set-Word/Barthlin Catheter - Panpac Medical - PDF Catalogs ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K130087 | Class II | Active |
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Manufacturer
- Manufacturer
- Panpac Medical Corporation
Sources (1)
- FDA 510(k) K130087 24 fields · synced Oct 1, 2026