Vitalcare Disposable Vaginal Speculum
FDA 510(k) K983716 · Vitalcare Group, Inc.
510(k) numberK983716
Submission
- Device name
- Vitalcare Disposable Vaginal Speculum
- Applicant
- Vitalcare Group, Inc.
Miami, FL, US - Received
- October 21, 1998
- Decision date
- December 23, 1998
- 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 |
| 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 |
More from Depalt, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K060109 | Omi Retractable Safety SyringeMEG · Traditional | 05/05/2006SE |
| K050906 | Vitalcare I.V. Administration SetFPA · Traditional | 08/23/2005SE |
| K040916 | Vitalcare Powder Free Synthetic Vinyl Examination GloveLYZ · Traditional | 05/04/2005SE |
| K031748 | Vitalcare Sterilewater and 0.9% Sodium Chloride Pre-Filled 10CC/30CC SyringesEZL · Traditional | 08/27/2003SE |
| K992289 | Vinyl Powdered Exam Glove / Cat.# 15-020LYZ · Traditional | 08/04/1999SE |
| K983016 | Gauze, Sponges, Cat # 11-003EFQ · Traditional | 02/12/1999SE |
| K982901 | Latex Patient Examination Glove, Cat. No. 1000M PowderedLYY · Traditional | 12/21/1998SE |
Questions and answers
When was Vitalcare Disposable Vaginal Speculum cleared by the FDA?
Vitalcare Disposable Vaginal Speculum (K983716) received a 510(k) decision of Substantially Equivalent on December 23, 1998, 63 days after the submission was received.
What is the product code of K983716?
The FDA product code is HIB – Speculum, Vaginal, Nonmetal, a Class II (moderate risk) device regulated under 21 CFR 884.4530.