Pelvic Exam Tray
FDA 510(k) K934732 · Medcare Custom Packaging, Inc.
510(k) numberK934732
Submission
- Device name
- Pelvic Exam Tray
- Applicant
- Medcare Custom Packaging, Inc.
E Swanzey, NH, US - Received
- September 29, 1993
- Decision date
- December 30, 1994
- 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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|---|---|---|---|
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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 |
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| K952759 | Towel PackKKX · Traditional | 09/29/1995SE |
| K950390 | Urethral Catheterization TrayFCM · Traditional | 05/30/1995SE |
| K943661 | Sterile Physiological Saline/Sterile WaterJOL · Traditional | 04/10/1995SE |
| K951149 | Single Use Instrument TrayLRO · Traditional | 04/06/1995SESK |
| K942000 | Burn Dressing TrayFRG · Traditional | 05/20/1994SESK |
| K936261 | Catheter Insertion TrayFMI · Traditional | 03/10/1994SESK |
| K922179 | Catheter Insertion TrayFMI · Traditional | 07/02/1993SEKD |
| K901856 | Custom Wound Management Kits and TraysLRO · Traditional | 08/01/1990SESD |
Questions and answers
When was Pelvic Exam Tray cleared by the FDA?
Pelvic Exam Tray (K934732) received a 510(k) decision of Substantially Equivalent on December 30, 1994, 457 days after the submission was received.
What is the product code of K934732?
The FDA product code is HHT – Spatula, Cervical, Cytological, a Class II (moderate risk) device regulated under 21 CFR 884.4530.