Video Colposcope/Vertical Rolling Base/Swing Arm Stand
FDA 510(k) K955635 · Welch Allyn, Inc.
510(k) numberK955635
Submission
- Device name
- Video Colposcope/Vertical Rolling Base/Swing Arm Stand
- Applicant
- Welch Allyn, Inc.
Skaneateles Falls, NY, US - Received
- December 11, 1995
- Decision date
- May 7, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
Other 510(k)s with product code HEX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K160341 | Colposcope SystemHEX · Traditional | Xuzhou Kernel Medical Equipment Co., Ltd. | 09/14/2016SE |
| 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 |
More from Lutech Industries, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K243598 | Welch Allyn Connex® 360 (Multiple) · Traditional | 07/13/2025SE |
| K241411 | Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)MWI · Traditional | 12/20/2024SE |
| K223381 | iExaminer System with Panoptic PlusHKI · Traditional | 03/15/2023SE |
| K212473 | Welch Allyn Connex Central StationMWI · Traditional | 10/28/2022SE |
| K191013 | Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry optionBZG · Traditional | 09/10/2019SE |
| K181016 | Welch Allyn RetinaVue Network REF 901108 PACS Medical Image SystemNFJ · Traditional | 07/16/2018SE |
| K171621 | Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System…MHX · Special | 06/30/2017SE |
| K142356 | Connex Spot Monitor,901058 Vital Signs Monitor CoreMWI · Traditional | 12/19/2014SE |
| K141582 | CP150 Electrocardiograph with Spirometry OptionDPS · Special | 07/11/2014SE |
| K132807 | Monitoring Station, Connex(R) Central Station (CS)MWI · Special | 01/31/2014SE |
Questions and answers
When was Video Colposcope/Vertical Rolling Base/Swing Arm Stand cleared by the FDA?
Video Colposcope/Vertical Rolling Base/Swing Arm Stand (K955635) received a 510(k) decision of Substantially Equivalent on May 7, 1996, 148 days after the submission was received.
What is the product code of K955635?
The FDA product code is HEX – Colposcope (And Colpomicroscope), a Class II (moderate risk) device regulated under 21 CFR 884.1630.