Panpac Word/Bartholin Catheter
FDA 510(k) K130087 · Panpac Medical Corporation
510(k) numberK130087
Submission
- Device name
- Panpac Word/Bartholin Catheter
- Applicant
- Panpac Medical Corporation
Shi-Chih City, Taipei Hsien, TW - Received
- January 14, 2013
- Decision date
- January 10, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KNA – Instrument, Manual, Specialized Obstetric-Gynecologic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4530
- Specialty
- Obstetrics/Gynecology
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K102141 | Cook Word Bartholin Gland Catheter (Final Trade Name Not Yet Determined)KNA · Traditional | Cook Urological, Inc. | 05/06/2011SE |
| K093904 | Glenveigh Vaginal Tamponade Balloon CatheterKNA · Traditional | Glenveigh Surgical, LLC | 04/14/2010SE |
| K082939 | Cook Fetal Membrane Manipulator, Model -FMM-122400KNA · Traditional | Cook Urological, Inc. | 09/03/2009SE |
| K062438 | Bakri Postpartum Balloon, Model J-SOS-100500KNA · Traditional | Cook Ob/Gyn | 10/27/2006SE |
| K060289 | Epistat, V-Stat, Models EPISTAT-001-01, V-STAT-001-01KNA · Traditional | Frontline Medical | 07/07/2006SE |
| K013597 | Tamponade Uterine Balloon Catheter SetKNA · Traditional | Cook Ob/Gyn | 04/17/2002SE |
| K014248 | DND 202 Manual Urological Digital Needle DriverKNA · Traditional | Urogyn , Ltd. | 03/21/2002SE |
| K001590 | DND 101KNA · Traditional | Urogyn , Ltd. | 08/02/2000SE |
| K990738 | Dr. Jahanger's CutterKNA · Traditional | M.S. Jahanger, MD | 10/29/1999SE |
| K990045 | Beraclamp, Model BC-1KNA · Traditional | Poamax LLC | 05/24/1999SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K173351 | Panpac Flexi Shelf PessaryHHW · Abbreviated | 10/31/2018SE |
| K161106 | Panpac Disposable Vacuum CurettesHGH · Traditional | 01/13/2017SE |
| K153422 | Panpac Disposable Pessary Fitting SetHHW · Special | 07/14/2016SE |
| K132670 | Panpac Inflatable Docut PessaryHHW · Traditional | 06/04/2014SE |
| K130273 | Panpac Vaginal DilatorsHDX · Traditional | 08/08/2013SE |
| K102898 | Bellota Sonohysterography Catheter with Cervical Cone, Bellota Sonohysterography…LKF · Traditional | 12/15/2011SE |
| K092982 | The Panpac Suction CuretteHHK · Traditional | 07/26/2010SE |
| K092981 | Panpac Vaginal PessaryHHW · Traditional | 07/22/2010SE |
| K092983 | Panpac HSG Catheter SetLKF · Traditional | 06/07/2010SE |
| K092984 | Panpac Uterine Inector, Model UI-4.0, UI-2.0LKF · Traditional | 04/07/2010SE |
Questions and answers
When was Panpac Word/Bartholin Catheter cleared by the FDA?
Panpac Word/Bartholin Catheter (K130087) received a 510(k) decision of Substantially Equivalent on January 10, 2014, 361 days after the submission was received.
What is the product code of K130087?
The FDA product code is KNA – Instrument, Manual, Specialized Obstetric-Gynecologic, a Class II (moderate risk) device regulated under 21 CFR 884.4530.