Kensorb
FDA 510(k) K953830 · Kentron Health Care, Inc.
510(k) numberK953830
Submission
- Device name
- Kensorb
- Applicant
- Kentron Health Care, Inc.
Hollywood, FL, US - Received
- August 16, 1995
- Decision date
- October 3, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GDY – Gauze/Sponge, Internal, X-Ray Detectable
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 878.4450
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code GDY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K972634 | Ultracell Suction SpongeGDY · Traditional | Ultracell Medical Technologies, Inc. | 12/17/1997SE |
| K960236 | CPR Lap SpongesGDY · Traditional | Custom Pack Reliability | 03/28/1996SE |
| K955599 | Stryker Femoral Canal Sponge & Acetabulum SpongeGDY · Traditional | Stryker Corp. | 02/22/1996SE |
| K955322 | Protec X-Ray Detectable Gauze SpongeGDY · Traditional | Derivados DE Gasa, S.A. DE C.V. | 12/19/1995SE |
| K953088 | Triangular SpongesGDY · Traditional | Medical Perspectives Corp. | 09/14/1995SE |
| K953087 | Cherry Pit DissectorGDY · Traditional | Medical Perspectives Corp. | 09/14/1995SE |
| K953062 | Cherry DissectorGDY · Traditional | Medical Perspectives Corp. | 09/14/1995SE |
| K953060 | Rosebud DissectorGDY · Traditional | Medical Perspectives Corp. | 09/14/1995SE |
| K953059 | Kittner DissectorGDY · Traditional | Medical Perspectives Corp. | 09/14/1995SE |
| K953058 | Round Stick Sponges, Flat Stick SpongesGDY · Traditional | Medical Perspectives Corp. | 09/14/1995SE |
More from Medical Perspectives Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K030693 | Kentex Disposable Vaginal SpeculumHIB · Traditional | 08/27/2003SE |
| K972410 | Impervious Isolation GownFYC · Traditional | 09/19/1997SE |
| K971917 | Kentron's Isolation GownFYC · Traditional | 09/19/1997SE |
| K953465 | KentempFLK · Traditional | 12/15/1995SE |
| K953914 | KentexEFQ · Traditional | 11/06/1995SE |
Questions and answers
When was Kensorb cleared by the FDA?
Kensorb (K953830) received a 510(k) decision of Substantially Equivalent on October 3, 1995, 48 days after the submission was received.
What is the product code of K953830?
The FDA product code is GDY – Gauze/Sponge, Internal, X-Ray Detectable, a Class I (low risk) device regulated under 21 CFR 878.4450.