510(k) K153128
- Device
- Kolplast Cervical Sample Collection Kit
- Applicant
- KOLPLAST CI SA
- 510(k) number
- K153128
- Product code
- HHT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-01-13
- Date received
- 2015-10-29
- Regulation
- 884.4530
- Classification name
- Spatula, Cervical, Cytological
- Medical specialty
- Obstetrics/Gynecology
- Review panel
- Pathology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DANIELA FERACIN
- Address
- Estrada Municipal Iva 136. No 418. Barrio Da Mina Itupeva- Sp BR 13295-000 13295-000
FDA Registration Numbers#
- 9680221
- 1423537
- 1450908
- 1063851
- 3010173425
- 9680254
- 8043235
- 1220477
- 3007496191
- 3005327291
- 8044093
- 1216677
- 2246552
- 2023790
- 1422634
- 2431166
- 3006191977
- 1216735
- 3005987240
- 2027344
- 3010047203
- 3009034535
- 3005941719
- 3009337401
- 3015895045
- 3044182936
- 1051594
- 3002732769
- 1319639
- 1122376
- 3003965134
- 3004105180
Source Documents#
Other 510(k) Records For Product Code HHT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K182049 | exCellerator Cervical Collection Device | Excell Company, LLC | 2019-04-25 |
| K141057 | DISPOSABLE CERVICAL BRUSH | Ningbo Hls Medical Products Co., Ltd. | 2015-05-14 |
| K111681 | HISTOBRUSH | Puritan Medical Products Company, LLC | 2012-01-19 |
| K083012 | PAPCONE | Otto Bock Pur Life Science GmbH | 2009-04-09 |
| K081522 | BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY | Bio Nuclear Diagnostics, Inc. | 2008-12-05 |
| K072381 | SOFTPAP CERVICAL CELL COLLECTOR | Cytocore, Inc. | 2008-01-30 |
| K062433 | DIAMICS CERCOL CERVICAL SAMPLE COLLECTOR SYSTEM | Diamics, Inc. | 2007-03-16 |
| K043369 | CERVEX-BRUSH COMBI | Rovers Medical Devices B.V. | 2005-02-02 |
| K042527 | SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107 | Medical Action Industries, Inc. | 2004-11-08 |
| K041018 | DRG SOFTRELEASE | Doctor'S Research Group, Inc. | 2004-10-18 |
| K013258 | INPATH E2 COLLECTOR | Molecular Diagnostics | 2002-05-31 |
| K002520 | ROVERS SPATULA | Rovers Medical Devices B.V. | 2000-11-13 |
| K001119 | ROVERS ENDOCERVEX-BRUSH | Rovers Medical Devices B.V. | 2000-05-19 |
| K991593 | ORIBRUSH - STANDARD - B002 | Orifice Medical AB | 1999-06-29 |
| K991595 | ORIBRUSH - WITH PROTECTIVE TIP - B001 | Orifice Medical AB | 1999-06-29 |
Legacy Summary#
summary
FDA Review#
Decision Summary