Pap Smear Kit
FDA 510(k) K862242 · Quali-Med, Inc.
510(k) numberK862242
Submission
- Device name
- Pap Smear Kit
- Applicant
- Quali-Med, Inc.
Sugar Land, TX, US - Received
- June 12, 1986
- Decision date
- June 26, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HHT – Spatula, Cervical, Cytological
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4530
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HHT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K182049 | exCellerator Cervical Collection DeviceHHT · Traditional | Excell Company, LLC | 04/25/2019SE |
| K153128 | Kolplast Cervical Sample Collection KitHHT · Traditional | Kolplast CI SA | 01/13/2017SE |
| K141057 | Disposable Cervical BrushHHT · Traditional | Ningbo Hls Medical Products Co., Ltd. | 05/14/2015SE |
| K111681 | HistobrushHHT · Traditional | Puritan Medical Products Company, LLC | 01/19/2012SE |
| K083012 | PapconeHHT · Traditional | Otto Bock Pur Life Science GmbH | 04/09/2009SE |
| K081522 | Bio Nuclear Diagnostics (Endo)Cervical Sampler for Gyn CytologyHHT · Traditional | Bio Nuclear Diagnostics, Inc. | 12/05/2008SE |
| K072381 | Softpap Cervical Cell CollectorHHT · Special | Cytocore, Inc. | 01/30/2008SE |
| K062433 | Diamics Cercol Cervical Sample Collector SystemHHT · Traditional | Diamics, Inc. | 03/16/2007SE |
| K043369 | Cervex-Brush CombiHHT · Traditional | Rovers Medical Devices B.V. | 02/02/2005SE |
| K042527 | Spatula, Cervical, Cytological, Model 22-9107HHT · Traditional | Medical Action Industries, Inc. | 11/08/2004SE |
More from Medical Action Industries, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K871408 | Blood Vessel Connector · Traditional | 04/27/1987SE |
| K862972 | Disposable Mirror · Traditional | 09/23/1986SE |
| K862472 | Quartz Rods Titanium RodsGEX · Traditional | 09/12/1986SE |
| K862241 | Standard Basin Kit Custom Basin KitFRG · Traditional | 08/01/1986SE |
| K862172 | Quali-Med's Operating Room DrapesKKX · Traditional | 06/19/1986SE |
| K861198 | Custom Procedure Kit (Various Sub-Titles) · Traditional | 05/16/1986SESD |
Questions and answers
When was Pap Smear Kit cleared by the FDA?
Pap Smear Kit (K862242) received a 510(k) decision of Substantially Equivalent on June 26, 1986, 14 days after the submission was received.
What is the product code of K862242?
The FDA product code is HHT – Spatula, Cervical, Cytological, a Class II (moderate risk) device regulated under 21 CFR 884.4530.