FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICROPOROUS HYPOALLERGENIC
K Number: K840946
·
Decision Aug 17, 1984
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
8
Applicant Total
11
Review Days
165
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Basic Information
- Device Name
- MICROPOROUS HYPOALLERGENIC
- K Number
- K840946
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Gainor Medical
- Date Received
- March 5, 1984
- Decision Date
- August 17, 1984
- Product Code
- KGW
- 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 |
|---|---|---|---|
| KGW | Ring (Wound Protector), Drape Retention, Internal | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KGW), ordered by most recent decision date.
Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted wound protector-retractor, flexible, small (cl301);Alexis lighted wound protector-retractor, flexible, medium (cl302);Alexis lighted wound protector-retractor, flexible, large (cl303);Alexis lighted wound protector-retractor, rigid, small (cl401);Alexis lighted wound protector-retractor, rigid, medium (cl402); Alexis lighted wound protector-retractor, rigid, large (cl403)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ALEXIS O WOUND PROTECTOR/RETRACTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ALEXIS ORTHOPAEDIC WOUND RETRACTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ALEXIS LAPAROSCOPIC SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ALEXIS WOUND RETRACTOR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Gainor Medical
| K Number | Device Name | ||
|---|---|---|---|
| K850100 | BLOOD LANCET | Jan 29, 1987 | Substantially Equivalent |
| K850150 | ULSTER SCIENTIFIC, INC. AUTOLET LANCETS/GAINOR MED | Feb 21, 1985 | Substantially Equivalent |
| K844306 | GAINOR MEDICAL SYRINGE | Nov 30, 1984 | Substantially Equivalent |
| K844305 | GAINOR MEDICAL FLOWMAX NEEDLES | Nov 30, 1984 | Substantially Equivalent |
| K840951 | FIRST AID BANDAGE | Oct 31, 1984 | Substantially Equivalent |
| K840950 | ZINC OXIDE TAPE | Oct 31, 1984 | Substantially Equivalent |
| K840945 | SKIN CLOSURE | Oct 31, 1984 | Substantially Equivalent |
| K840947 | CLOTH-HYPOALLERGENIC | Aug 17, 1984 | Substantially Equivalent |
| K840949 | CLEAR PLASTIC-HYPOALLERGENIC | Aug 17, 1984 | Substantially Equivalent |
| K840948 | CLEAR POROUS PLASTIC-HYPOALLERGENIC | Aug 14, 1984 | Substantially Equivalent |