FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Maxima Surgical Gown
K Number: K201351
·
Decision Mar 11, 2022
Classifications
1
FEI Numbers
218
Registration Numbers
218
Same Product Code
287
Applicant Total
1
Review Days
659
Basic Information
- Device Name
- Maxima Surgical Gown
- K Number
- K201351
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Elevate Textiles
- Date Received
- May 21, 2020
- Decision Date
- March 11, 2022
- Product Code
- FYA
- 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 |
|---|---|---|---|
| FYA | Gown, Surgical | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FYA), ordered by most recent decision date.
ViVi® Toga Premium
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Dream Medi Sterile Surgical Gown (SurgicalGownUL)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Medline Level 4 Surgical Gown with Breathable Sleeves
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Stryker Steri-Shield 8 Surgical Hoods and Togas
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ProPel SG3 Surgical Gown
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
GCI Surgical Gown
FDA 510(k)
FDA Class 2
·General, Plastic Surgery