Ortho* Specimen Collection Cytology Brush
FDA 510(k) K875162 · Ortho Diagnostic Systems, Inc.
510(k) numberK875162
Submission
- Device name
- Ortho* Specimen Collection Cytology Brush
- Applicant
- Ortho Diagnostic Systems, Inc.
Carpinteria, CA, US - Received
- December 16, 1987
- Decision date
- January 27, 1988
- 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 |
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| 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 |
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Questions and answers
When was Ortho* Specimen Collection Cytology Brush cleared by the FDA?
Ortho* Specimen Collection Cytology Brush (K875162) received a 510(k) decision of Substantially Equivalent on January 27, 1988, 42 days after the submission was received.
What is the product code of K875162?
The FDA product code is HHT – Spatula, Cervical, Cytological, a Class II (moderate risk) device regulated under 21 CFR 884.4530.