FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
SURGICAL DRAPES AND DRAPE ACCESSORIES
K Number: K862438
·
Decision Jul 16, 1986
Classifications
1
FEI Numbers
200
Registration Numbers
200
Same Product Code
449
Applicant Total
12
Review Days
20
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Basic Information
- Device Name
- SURGICAL DRAPES AND DRAPE ACCESSORIES
- K Number
- K862438
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Avery Intl.
- Date Received
- June 26, 1986
- Decision Date
- July 16, 1986
- Product Code
- KKX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| KKX | Drape, Surgical, Antimicrobial | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Avery Intl.
| K Number | Device Name | ||
|---|---|---|---|
| K870092 | MEDICAL ADHESIVE TAPE & BANDAGE USING HYTREL FILM | Feb 5, 1987 | Substantially Equivalent for Some Indications |
| K870093 | MEDICAL ADHESIVE TAPE & BANDAGE USING PCCE FILM | Feb 5, 1987 | Substantially Equivalent for Some Indications |
| K870021 | MEDICAL ADHESIVE TAPE AND ADHESIVE BANDAGE | Feb 5, 1987 | Substantially Equivalent for Some Indications |
| K870090 | IV SECUREMENT DEVICE USING HYTREL THERMO. FILM | Feb 4, 1987 | Substantially Equivalent |
| K870123 | SURGICAL DRAPES AND ACCESSORIES USING PCCE FILM | Feb 4, 1987 | Substantially Equivalent |
| K870122 | SURGICAL DRAPES AND ACCESSORIES USING HYTREL FILM | Feb 4, 1987 | Substantially Equivalent |
| K870124 | SURGICAL DRAPES AND ACCESSORIES USING PEBAX FILM | Feb 4, 1987 | Substantially Equivalent |
| K870091 | IV SECUREMENT DEVICE USING PCCE THERMO. FILM | Feb 4, 1987 | Substantially Equivalent |
| K870020 | IV SECUREMENT DEVICE | Feb 4, 1987 | Substantially Equivalent |
| K854463 | ADHESIVE TAPE, WOUND CARE, WOUND DRESSING | Mar 3, 1986 | Substantially Equivalent for Some Indications |