Colposcope System
FDA 510(k) K160341 · Xuzhou Kernel Medical Equipment Co., Ltd.
510(k) numberK160341
Submission
- Device name
- Colposcope System
- Applicant
- Xuzhou Kernel Medical Equipment Co., Ltd.
Xuzhou, CN - Received
- February 8, 2016
- Decision date
- September 14, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HEX – Colposcope (And Colpomicroscope)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.1630
- Specialty
- Obstetrics/Gynecology
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|---|---|---|---|
| K233043 | Smart Scope® CXHEX · Traditional | Periwinkle Technologies Pvt., Ltd. | 06/14/2024SE |
| K190187 | Gynescope SystemHEX · Traditional | Illumigyn , Ltd. | 05/08/2019SE |
| K182764 | Biop Digital ColposcopeHEX · Traditional | Biop Medical , Ltd. | 11/27/2018SE |
| K181034 | Pocket Colposcope SystemHEX · Traditional | Hadleigh Health Technologies, LLC | 09/21/2018SE |
| K170446 | LT-300 SD Digital Video ColposcopeHEX · Traditional | Lutech Industries, Inc. | 05/21/2017SE |
| K161871 | EVA (Enhanced Visual Assessment) SystemHEX · Traditional | Mobileodt , Ltd. | 12/19/2016SE |
| K160380 | LT-300 HDHEX · Traditional | Lutech Industries, Inc. | 05/13/2016SE |
| K151878 | Video ColposcopeHEX · Traditional | Edan Instruments, Inc. | 12/01/2015SE |
| K143119 | LT-300 Video ColposcopeHEX · Traditional | Lutech Industries, Inc. | 12/18/2014SE |
| K140754 | Cooper Surgical Leisegang Colposcope SystemHEX · Traditional | CooperSurgical, Inc. | 10/23/2014SE |
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| K242977 | 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D…FTC · Traditional | 02/06/2025SE |
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| K200929 | Hair Growth SystemOAP · Traditional | 06/03/2020SE |
| K190685 | Hair Growth SystemOAP · Traditional | 07/26/2019SE |
| K181805 | UV PhototherapyFTC · Traditional | 01/11/2019SE |
| K132643 | UV PhototherapyFTC · Traditional | 01/30/2014SE |
Questions and answers
When was Colposcope System cleared by the FDA?
Colposcope System (K160341) received a 510(k) decision of Substantially Equivalent on September 14, 2016, 219 days after the submission was received.
What is the product code of K160341?
The FDA product code is HEX – Colposcope (And Colpomicroscope), a Class II (moderate risk) device regulated under 21 CFR 884.1630.