Stericare Wound Care Gel
FDA 510(k) K951861 · Acacia Laboratories, Inc.
510(k) numberK951861
Submission
- Device name
- Stericare Wound Care Gel
- Applicant
- Acacia Laboratories, Inc.
Santa Ana, CA, US - Received
- April 21, 1995
- Decision date
- July 11, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MGQ – Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
- Device class
- Unclassified
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More from Cardiotech Intl.
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| K952414 | Prefilled Syringe for Inflation of Foley CatheterKNY · Traditional | 06/23/1995SE |
| K951914 | Hydracare Absorbent Wound DressingKMF · Traditional | 05/15/1995SN |
| K950344 | Horizon Foley Catheterization Tray Without CatheterFCM · Traditional | 03/24/1995SEKD |
| K913408 | Sterile Plastic DrapeKKX · Traditional | 03/12/1992SE |
| K901761 | Sterile Suction Tubing SetBYY · Traditional | 05/07/1990SE |
| K892856 | Newmark(Tm) Coronary Artery Bypass Graft MarkersKRI · Traditional | 11/08/1989SE |
| K892804 | Newchill(Tm) Cardiac InsulatorDWS · Traditional | 07/14/1989SE |
| K884055 | Surgi-Tag(Tm) Sterile Label SetsLYV · Traditional | 10/13/1988SE |
Questions and answers
When was Stericare Wound Care Gel cleared by the FDA?
Stericare Wound Care Gel (K951861) received a 510(k) decision of Substantially Equivalent on July 11, 1995, 81 days after the submission was received.
What is the product code of K951861?
The FDA product code is MGQ – Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic, a Unclassified device.