CURAGEL HYDROGEL WOUND DRESSING
FDA 510(k) clearance K950412 · decided 1995-03-24
Clearance details
- K-number
- K950412
- Device name
- CURAGEL HYDROGEL WOUND DRESSING
- Applicant
- Kendall Healthcare Products Co. Div.Of Tyco Health
- Decision
- Substantially Equivalent
- Date received
- 1995-01-31
- Decision date
- 1995-03-24
- Days to decision
- 52 days
- Clearance type
- Traditional
- Product code
- NAE
- Device class
- 1
- Regulation number
- 878.4022
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mansfield, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO ZENIEVA (K083721) | River'S Edge Pharmaceuticals, LLC | 2009-01-08 |
| MODIFICATION TO ZENIEVA (K082865) | Gorbec Pharmaceutical Services, Inc. | 2008-10-23 |
| ZENIEVA (K073246) | Gorbec Pharmaceutical Services, Inc. | 2008-07-23 |
| GILTECH PLUS HYDROGEL SKIN DRESSING (K992094) | Giltech Plus, Inc. | 1999-09-17 |
| DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING (K991061) | Dermaphylyx, Inc. | 1999-06-28 |
| AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES (K972646) | Ludlow Technical Products | 1997-08-21 |
| COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903) (K971597) | Coloplast Corp. | 1997-07-29 |
| HYDROGEL SKIN DRESSING (K962352) | North American Sterilization & Packaging Co. | 1996-08-02 |
| AQUAFLO HYDROGEL WOUND DRESSING & PACKER (K952945) | Sherwood Medical Co. | 1995-08-23 |
| BIODERM MEDICAL HYDROGEL ISLAND DRESSING (K951166) | Bioderm, Inc. | 1995-06-21 |
| BRADY MEDICAL PRODUCTS TRANSCORBENT AND THINSITE TOPICAL BORDER WOUND DRESSINGS (K945832) | Brady Medical Products Co. | 1995-03-01 |
| INTRASITE (K942748) | Smith & Nephew United, Inc. | 1994-06-29 |
Recalls involving this device
No recalls on record reference this clearance.