FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SPENCO SILICONE GEL SHEET
K Number: K981902
·
Decision Jun 25, 1998
Classifications
1
FEI Numbers
190
Registration Numbers
190
Same Product Code
80
Applicant Total
10
Review Days
24
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SPENCO SILICONE GEL SHEET
- K Number
- K981902
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4025
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Spenco Medical Corp.
- Date Received
- June 1, 1998
- Decision Date
- June 25, 1998
- Product Code
- MDA
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MDA | Elastomer, Silicone, For Scar Management | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MDA), ordered by most recent decision date.
NEODYNE DRESSING
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CORELEADER SCAR-DIMMER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
BEAU RX SCAR CARE GEL
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
KELO-COTE SPRAY
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NEWGEL AND NEWGEL PLUS E
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
HANSON SCAR ADE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Spenco Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K922228 | 2ND SKIN STERILE ADHESIVE STRIP | Dec 11, 1992 | Unknown |
| K911550 | 2ND SKIN MOIST BURN PADS WITH ALOE | Sep 6, 1991 | Substantially Equivalent |
| K910927 | SPENCIO SKIN GUARD KIT | Jun 3, 1991 | Substantially Equivalent |
| K896533 | SPENCO BREAST FORMS | Dec 13, 1989 | Substantially Equivalent |
| K894898 | 2ND SKIN NON-STICK MOIST BURN PADS | Aug 23, 1989 | Substantially Equivalent |
| K820906 | SPENCO CRYOPRESS | May 13, 1982 | Substantially Equivalent |
| K811184 | SPENCO DERMAL PADS | May 20, 1981 | Substantially Equivalent |
| K791726 | HYDROGEL-PREP | Nov 20, 1979 | Substantially Equivalent |
| K791162 | GELSKIN | Sep 4, 1979 | Substantially Equivalent |