The Cabot Medical Insul-Sheth Vaginal Speculum Cov
FDA 510(k) K930954 · Cabot Medical Corp.
510(k) numberK930954
Submission
- Device name
- The Cabot Medical Insul-Sheth Vaginal Speculum Cov
- Applicant
- Cabot Medical Corp.
Langhorne, PA, US - Received
- February 23, 1993
- Decision date
- June 30, 1994
- 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 |
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| 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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| K941743 | Cabot Medical Niagara Fluid Management PumpHIG · Traditional | 04/19/1995SE |
| K934115 | 3000 Electronic Insufflator ModificationHIF · Traditional | 03/15/1995SE |
| K932293 | Cabot Medical Bipolar Cutting ForcepsKNS · Traditional | 07/27/1994SE |
| K932626 | Cabot Medical Surgiflex(R) Suction-Irrigation ProbGCJ · Traditional | 06/08/1994SE |
| K935786 | Corson and Nezhat Suction/Irrigation ProbesGCJ · Traditional | 05/19/1994SE |
| K924631 | Cabot Medical Uterine ResectoscopeHIH · Traditional | 05/16/1994SE |
Questions and answers
When was The Cabot Medical Insul-Sheth Vaginal Speculum Cov cleared by the FDA?
The Cabot Medical Insul-Sheth Vaginal Speculum Cov (K930954) received a 510(k) decision of Substantially Equivalent on June 30, 1994, 492 days after the submission was received.
What is the product code of K930954?
The FDA product code is HIB – Speculum, Vaginal, Nonmetal, a Class II (moderate risk) device regulated under 21 CFR 884.4530.