Amsino Disposable Viginal Speculum
FDA 510(k) K951528 · Amsino Intl., Inc.
510(k) numberK951528
Submission
- Device name
- Amsino Disposable Viginal Speculum
- Applicant
- Amsino Intl., Inc.
City Of Industry, CA, US - Received
- April 3, 1995
- Decision date
- May 11, 1995
- 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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| 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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| 510(k) | Device | Decision |
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| K070873 | Amsure Bladder Irrigation SetLJH · Traditional | 12/19/2007SE |
| K992719 | Amsure Enteral Delivery Pump Set with SpikeKNT · Traditional | 01/12/2000SE |
| K974042 | Amsure Cleansing Enema SetFCE · Traditional | 12/19/1997SE |
| K973107 | Amsino I.V. Administration SetFPA · Traditional | 10/02/1997SE |
| K973199 | Amsino Suction CatheterBSY · Traditional | 09/10/1997SE |
| K971929 | Amsino Urinary Leg BagKNX · Traditional | 08/06/1997SE |
| K964745 | Amsino Urinary Drainage BagKNX · Traditional | 03/18/1997SE |
| K950780 | Amsino Cervical ScraperHHT · Traditional | 07/25/1995SE |
Questions and answers
When was Amsino Disposable Viginal Speculum cleared by the FDA?
Amsino Disposable Viginal Speculum (K951528) received a 510(k) decision of Substantially Equivalent on May 11, 1995, 38 days after the submission was received.
What is the product code of K951528?
The FDA product code is HIB – Speculum, Vaginal, Nonmetal, a Class II (moderate risk) device regulated under 21 CFR 884.4530.