Office-Spec Disposable Side-Opening Speculum
FDA 510(k) K091937 · Obp Corporation
510(k) numberK091937
Submission
- Device name
- Office-Spec Disposable Side-Opening Speculum
- Applicant
- Obp Corporation
Lawerence, MA, US - Received
- June 30, 2009
- Decision date
- September 9, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| 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 |
More from Welch Allyn, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K121604 | Anospec Disposable Ansoscope with LightFER · Traditional | 07/27/2012SE |
Questions and answers
When was Office-Spec Disposable Side-Opening Speculum cleared by the FDA?
Office-Spec Disposable Side-Opening Speculum (K091937) received a 510(k) decision of Substantially Equivalent on September 9, 2009, 71 days after the submission was received.
What is the product code of K091937?
The FDA product code is HIB – Speculum, Vaginal, Nonmetal, a Class II (moderate risk) device regulated under 21 CFR 884.4530.