FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SURESEAL BANDAGE
K Number: K922441
·
Decision Aug 10, 1993
Classifications
1
FEI Numbers
972
Registration Numbers
972
Same Product Code
186
Applicant Total
13
Review Days
445
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Basic Information
- Device Name
- SURESEAL BANDAGE
- K Number
- K922441
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5240
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Gainor Medical Europe, Ltd.
- Date Received
- May 22, 1992
- Decision Date
- August 10, 1993
- 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
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SYVEK PATCH
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ADHESIVE BANDAGES WITH OTC DRUG
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TARGETT PATCH
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PARALLEL
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Other Clearances by Gainor Medical Europe, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K926448 | I.V. ADMINISTRATION SET | May 2, 1994 | Substantially Equivalent |
| K931828 | CARELET SAFETY LANCET | Oct 15, 1993 | Substantially Equivalent |
| K931827 | CLEANLET, CLEANLET XL & KIDS | Sep 13, 1993 | Substantially Equivalent |
| K913333 | I.V. PRIMING SET | Oct 23, 1991 | Substantially Equivalent |
| K902422 | NEEDLE, ASPIRATION & INJECTION, DISPOSABLE | Jun 6, 1991 | Substantially Equivalent |
| K902420 | CATHETER, NASAL, OXYGEN | Apr 17, 1991 | Substantially Equivalent |
| K902564 | NEEDLE, DIALYSIS | Mar 1, 1991 | Substantially Equivalent |
| K902426 | HEMODIALYSIS SYSTEM AND ACCESSORY | Nov 20, 1990 | Substantially Equivalent |
| K902421 | STOMACH, GASTRO-ENTEROSTOMY | Nov 20, 1990 | Substantially Equivalent |
| K902416 | SURELITE AND SURELITE XL BLOOD LANCET | Aug 1, 1990 | Substantially Equivalent |