Dukal Disposable Vaginal Speculum, Small, Medium, and Large
FDA 510(k) K020726 · Dukal Corp.
510(k) numberK020726
Submission
- Device name
- Dukal Disposable Vaginal Speculum, Small, Medium, and Large
- Applicant
- Dukal Corp.
New Port Riche, FL, US - Received
- March 6, 2002
- Decision date
- May 15, 2002
- 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 |
| K110766 | Kolplux SystemHIB · Traditional | Kolplast CI Ltda | 09/15/2011SE |
| 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 |
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Questions and answers
When was Dukal Disposable Vaginal Speculum, Small, Medium, and Large cleared by the FDA?
Dukal Disposable Vaginal Speculum, Small, Medium, and Large (K020726) received a 510(k) decision of Substantially Equivalent on May 15, 2002, 70 days after the submission was received.
What is the product code of K020726?
The FDA product code is HIB – Speculum, Vaginal, Nonmetal, a Class II (moderate risk) device regulated under 21 CFR 884.4530.