FDA 510(k)
FDA class 1
Unknown
🇺🇸 United States
2ND SKIN STERILE ADHESIVE STRIP
K Number: K922228
·
Decision Dec 11, 1992
Classifications
1
FEI Numbers
972
Registration Numbers
972
Same Product Code
186
Applicant Total
10
Review Days
213
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
- 2ND SKIN STERILE ADHESIVE STRIP
- K Number
- K922228
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5240
- Medical Specialty
- General Hospital
- Decision
- Unknown
- Statement or Summary
- Statement
- Applicant
- Spenco Medical Corp.
- Date Received
- May 12, 1992
- Decision Date
- December 11, 1992
- Product Code
- KGX
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| KGX | Tape And Bandage, Adhesive | FDA class 1 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KGX), ordered by most recent decision date.
SERAGARD INJECTION PATCH
FDA 510(k)
FDA Class 1
·General Hospital
CARE BAND ANTIBACTERIAL BANDAGES
FDA 510(k)
FDA Class 1
·General Hospital
SYVEK PATCH
FDA 510(k)
FDA Class 1
·General Hospital
ADHESIVE BANDAGES WITH OTC DRUG
FDA 510(k)
FDA Class 1
·General Hospital
TARGETT PATCH
FDA 510(k)
FDA Class 1
·General Hospital
PARALLEL
FDA 510(k)
FDA Class 1
·General Hospital
Other Clearances by Spenco Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K981902 | SPENCO SILICONE GEL SHEET | Jun 25, 1998 | Substantially Equivalent |
| 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 |