Surgi-Pap Kit
FDA 510(k) K850676 · Surgipath Medical Industries, Inc.
510(k) numberK850676
Submission
- Device name
- Surgi-Pap Kit
- Applicant
- Surgipath Medical Industries, Inc.
Grayslake, IL, US - Received
- February 21, 1985
- Decision date
- March 22, 1985
- 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
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| 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 |
|---|---|---|
| K883217 | Schiff ReagentHZT · Traditional | 08/05/1988SE |
| K881921 | C-E BrushHHT · Traditional | 07/19/1988SE |
| K881922 | Cytojars Prefilled with Cytology PreservativeLDZ · Traditional | 05/25/1988SE |
| K881659 | Tissue Section AdhesiveIFZ · Traditional | 04/21/1988SE |
| K863549 | Reusable/Disposable Autopsy Knife SetEMF · Traditional | 09/30/1986SE |
| K863616 | Knife MakerIDL · Traditional | 09/25/1986SE |
| K863548 | Rotary MicrotomeIDO · Traditional | 09/19/1986SE |
| K863483 | Cassette EmbosseerIDZ · Traditional | 09/16/1986SE |
| K863145 | Cervical ScrapersHHT · Traditional | 08/19/1986SE |
| K861270 | Blue Ribbon Paraffin Infiltration/Embedding Med.KEO · Traditional | 04/11/1986SE |
Questions and answers
When was Surgi-Pap Kit cleared by the FDA?
Surgi-Pap Kit (K850676) received a 510(k) decision of Substantially Equivalent on March 22, 1985, 29 days after the submission was received.
What is the product code of K850676?
The FDA product code is HHT – Spatula, Cervical, Cytological, a Class II (moderate risk) device regulated under 21 CFR 884.4530.