Kolplux System
FDA 510(k) K110766 · Kolplast CI Ltda
510(k) numberK110766
Submission
- Device name
- Kolplux System
- Applicant
- Kolplast CI Ltda
Crofton, MD, US - Received
- March 18, 2011
- Decision date
- September 15, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HIB – Speculum, Vaginal, Nonmetal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.4530
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code HIB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252208 | JFord Speculum SleeveHIB · Traditional | Ford Medtech, LLC | 03/06/2026SE |
| K133857 | Brella-Spec(Tm) Vaginal SpeculumHIB · Traditional | Proa Medical, Inc. | 04/28/2014SE |
| K132668 | Iob Disposable SpeculumHIB · Traditional | Iob Medical, Inc. | 01/17/2014SE |
| K130046 | Clearspec Single Use Vaginal SpeculumHIB · Traditional | Clearspec, LLC | 08/06/2013SE |
| K120743 | Speculum, Vaginal, NonmetalHIB · Special | Welch Allyn, Inc. | 03/23/2012SE |
| K092870 | Non-Sterile Disposable Vaginal SpeculumHIB · Traditional | Kunshan Deyi Plastic Co., Ltd. | 02/16/2010SE |
| K091937 | Office-Spec Disposable Side-Opening SpeculumHIB · Traditional | Obp Corporation | 09/09/2009SE |
| K072942 | Medline Disposable Vaginal SpeculumHIB · Traditional | Medline Industries, Inc. | 02/08/2008SE |
| K072762 | Depalt Vaginal Specuim and Depalt Lighting SystemHIB · Traditional | Depalt, Inc. | 01/22/2008SE |
| K070964 | Kleenspec Single Use Vaginal Speculum and 790 Series Cordless Illumination SystemHIB · Special | Welch Allyn, Inc. | 05/18/2007SE |
Questions and answers
When was Kolplux System cleared by the FDA?
Kolplux System (K110766) received a 510(k) decision of Substantially Equivalent on September 15, 2011, 181 days after the submission was received.
What is the product code of K110766?
The FDA product code is HIB – Speculum, Vaginal, Nonmetal, a Class II (moderate risk) device regulated under 21 CFR 884.4530.