Wallach's Ultimate Reusable, Plastic Vaginal Speculum
FDA 510(k) K992736 · Wallach Surgical Devices, Inc.
510(k) numberK992736
Submission
- Device name
- Wallach's Ultimate Reusable, Plastic Vaginal Speculum
- Applicant
- Wallach Surgical Devices, Inc.
Orange, CT, US - Received
- August 13, 1999
- Decision date
- September 29, 1999
- 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
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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 |
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| K000768 | Wallach Quantum 500 Electrosurgical GeneratorEKZ · Traditional | 04/11/2000SE |
| K991669 | PMS 750 FingerswitchGEI · Traditional | 08/12/1999SE |
| K983840 | Wallach Quantum 500 Electrosurgical Generator (Proposed)HGI · Traditional | 05/20/1999SE |
| K984306 | `The Inseminator' (Proposed)MFD · Traditional | 03/01/1999SE |
| K983208 | Wallach Quantum 500 Electrosurgical GeneratorGEI · Traditional | 02/22/1999SE |
| K963653 | Wallach Quantum 2000 Electrosurgical SystemHGI · Traditional | 06/11/1997SE |
| K963348 | Wallach Integration UnitHGI · Traditional | 03/19/1997SE |
| K950630 | Wallach Digital Imaging SystemLMB · Traditional | 11/22/1995SE |
Questions and answers
When was Wallach's Ultimate Reusable, Plastic Vaginal Speculum cleared by the FDA?
Wallach's Ultimate Reusable, Plastic Vaginal Speculum (K992736) received a 510(k) decision of Substantially Equivalent on September 29, 1999, 47 days after the submission was received.
What is the product code of K992736?
The FDA product code is HIB – Speculum, Vaginal, Nonmetal, a Class II (moderate risk) device regulated under 21 CFR 884.4530.