Cell Sweep
FDA 510(k) K911327 · Reza S Mohajer, M.D. C/O Krass & Young
510(k) numberK911327
Submission
- Device name
- Cell Sweep
- Applicant
- Reza S Mohajer, M.D. C/O Krass & Young
Troy, MI, US - Received
- March 26, 1991
- Decision date
- May 21, 1991
- 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 |
Questions and answers
When was Cell Sweep cleared by the FDA?
Cell Sweep (K911327) received a 510(k) decision of Substantially Equivalent on May 21, 1991, 56 days after the submission was received.
What is the product code of K911327?
The FDA product code is HHT – Spatula, Cervical, Cytological, a Class II (moderate risk) device regulated under 21 CFR 884.4530.