Cypress Medical Products, LP Disposable Vaginal Speculum, Non-Metal
FDA 510(k) K021676 · Cypress Medical Products, Ltd.
510(k) numberK021676
Submission
- Device name
- Cypress Medical Products, LP Disposable Vaginal Speculum, Non-Metal
- Applicant
- Cypress Medical Products, Ltd.
Mc Henry, IL, US - Received
- May 21, 2002
- Decision date
- July 12, 2002
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K012282 | Sterile Powder Free Synthetic Vinyl Patient Exam GloveLYZ · Traditional | 08/06/2001SE |
| K972899 | Cypress Medical Products Aneroid SphygmomanometerDXQ · Traditional | 07/07/1998SE |
| K972849 | Isosafe Earloop Procedure Mask (Blue, Yellow)FXX · Traditional | 05/28/1998SE |
| K972883 | Isosafe Earloop Procedure Mask (Blue, Yellow)FXX · Traditional | 02/26/1998SE |
| K952367 | Cypress Medical Products Vinyl Examination GloveLYY · Traditional | 07/05/1995SE |
| K950254 | Cypress Medical Products Sterile Latex Examination GloveLYY · Traditional | 03/31/1995SE |
| K950109 | Cypress Medical Products Catheter (Insertion) Tray/With Out CatheterFCM · Traditional | 02/27/1995SESK |
| K950092 | Cypress Medical Products Catheter (Insertion) TrayFCM · Traditional | 02/27/1995SESK |
| K945082 | Cypress Medical Products StethoscopeLDE · Traditional | 12/08/1994SE |
| K921988 | Laceration Repair TrayMDM · Traditional | 11/19/1992SEKD |
Questions and answers
When was Cypress Medical Products, LP Disposable Vaginal Speculum, Non-Metal cleared by the FDA?
Cypress Medical Products, LP Disposable Vaginal Speculum, Non-Metal (K021676) received a 510(k) decision of Substantially Equivalent on July 12, 2002, 52 days after the submission was received.
What is the product code of K021676?
The FDA product code is HIB – Speculum, Vaginal, Nonmetal, a Class II (moderate risk) device regulated under 21 CFR 884.4530.