Spatula, Cervical, Cytological, Model 22-9107
FDA 510(k) K042527 · Medical Action Industries, Inc.
510(k) numberK042527
Submission
- Device name
- Spatula, Cervical, Cytological, Model 22-9107
- Applicant
- Medical Action Industries, Inc.
Arden, NC, US - Received
- September 17, 2004
- Decision date
- November 8, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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| 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 |
| K041018 | DRG SoftreleaseHHT · Traditional | Doctor'S Research Group, Inc. | 10/18/2004SE |
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| K022948 | Vaginal Speculum, Model 5555S, 5555M, or 5555LHIB · Traditional | 11/04/2002SE |
| K946019 | Surgicla Instrument KitFRG · Traditional | 03/20/1995SE |
| K923846 | Burn DressingNAB · Traditional | 09/11/1992SE |
| K884826 | Gauze SpongeEFQ · Traditional | 12/22/1988SE |
| K810685 | Suture Removal KitGEN · Traditional | 03/26/1981SE |
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Questions and answers
When was Spatula, Cervical, Cytological, Model 22-9107 cleared by the FDA?
Spatula, Cervical, Cytological, Model 22-9107 (K042527) received a 510(k) decision of Substantially Equivalent on November 8, 2004, 52 days after the submission was received.
What is the product code of K042527?
The FDA product code is HHT – Spatula, Cervical, Cytological, a Class II (moderate risk) device regulated under 21 CFR 884.4530.