Wallach Cc/Brush
FDA 510(k) K896065 · Wallach Surgical Devices, Inc.
510(k) numberK896065
Submission
- Device name
- Wallach Cc/Brush
- Applicant
- Wallach Surgical Devices, Inc.
Milford, CT, US - Received
- October 18, 1989
- Decision date
- January 4, 1990
- 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 |
|---|---|---|
| K021224 | Endocervical Block NeedleHEE · Traditional | 07/12/2002SE |
| K020711 | Wallach Loop ElectrodeGEI · Traditional | 06/03/2002SE |
| K000768 | Wallach Quantum 500 Electrosurgical GeneratorEKZ · Traditional | 04/11/2000SE |
| K992736 | Wallach's Ultimate Reusable, Plastic Vaginal SpeculumHIB · Traditional | 09/29/1999SE |
| K991669 | PMS 750 FingerswitchGEI · Traditional | 08/12/1999SE |
| K983840 | Wallach Quantum 500 Electrosurgical Generator (Proposed)HGI · Traditional | 05/20/1999SE |
| K984306 | `The Inseminator' (Proposed)MFD · Traditional | 03/01/1999SE |
| K983208 | Wallach Quantum 500 Electrosurgical GeneratorGEI · Traditional | 02/22/1999SE |
| K963653 | Wallach Quantum 2000 Electrosurgical SystemHGI · Traditional | 06/11/1997SE |
| K963348 | Wallach Integration UnitHGI · Traditional | 03/19/1997SE |
Questions and answers
When was Wallach Cc/Brush cleared by the FDA?
Wallach Cc/Brush (K896065) received a 510(k) decision of Substantially Equivalent on January 4, 1990, 78 days after the submission was received.
What is the product code of K896065?
The FDA product code is HHT – Spatula, Cervical, Cytological, a Class II (moderate risk) device regulated under 21 CFR 884.4530.