FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURGIPLUS SMS SURGICAL DRAPE (STERILE/NON-STERILE), SURGIPLUS SPP WITH PE LAMINATED SURGICAL DRAPE (STERILE/NON-STERILE)
K Number: K102861
·
Decision Jan 13, 2011
Classifications
1
FEI Numbers
200
Registration Numbers
200
Same Product Code
449
Applicant Total
11
Review Days
105
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Basic Information
- Device Name
- SURGIPLUS SMS SURGICAL DRAPE (STERILE/NON-STERILE), SURGIPLUS SPP WITH PE LAMINATED SURGICAL DRAPE (STERILE/NON-STERILE)
- K Number
- K102861
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- A Plus International, Inc.
- Date Received
- September 30, 2010
- Decision Date
- January 13, 2011
- Product Code
- KKX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- HO
- Third Party
- Y
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 A Plus International, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K213001 | Procedure Mask, Surgical Mask | May 11, 2022 | Substantially Equivalent |
| K093169 | SURGIPLUS STANDARD SURGICAL GOWN (STERILE) ( NON STERILE), REINFORCED SURGICAL GOWN (STERILE) (NON STERILE) | Nov 12, 2009 | Substantially Equivalent |
| K031353 | SOLUTION FACE MASKS | Jun 19, 2003 | Substantially Equivalent |
| K882283 | BOUFFANT CAP | Jun 23, 1988 | Substantially Equivalent |
| K882281 | GOWN, ISOLATION, SURGICAL (FYC) | Jun 23, 1988 | Substantially Equivalent |
| K882284 | SURGEONS CAP | Jun 23, 1988 | Substantially Equivalent |
| K882282 | SUIT, SURGICAL | Jun 23, 1988 | Substantially Equivalent |
| K882280 | COVER, SHOE OPERATING ROOM | Jun 23, 1988 | Substantially Equivalent |
| K881396 | OPERATING ROOM TOWELS -STERILE & NON-STERILE | Apr 29, 1988 | Substantially Equivalent |
| K881395 | GAUZE AND LAP SPONGES -STERILE & NON-STERILE | Apr 28, 1988 | Substantially Equivalent |