FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HYDRAGOWN
K Number: K934664
·
Decision May 24, 1994
Classifications
1
FEI Numbers
222
Registration Numbers
222
Same Product Code
294
Applicant Total
27
Review Days
238
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- HYDRAGOWN
- K Number
- K934664
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Mallinckrodt Group, Inc.
- Date Received
- September 28, 1993
- Decision Date
- May 24, 1994
- 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.
Tuff Cuff Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Cardinal Health Poly Reinforced Surgical Gown
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Copioumed AAMI 3 Surgical Gown
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Henan Yadu Level 4 Surgical Gowns (Reinforced)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Mallinckrodt Group, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K945053 | LF CT HIG PRESSURE CATHETERS | May 19, 1995 | Substantially Equivalent |
| K945140 | URO-FLO | Mar 8, 1995 | Substantially Equivalent |
| K943581 | HYDRADJUST IV UROLOGICAL TABLE | Jan 4, 1995 | Substantially Equivalent |
| K943122 | SURGICAL DRAPES | Sep 7, 1994 | Substantially Equivalent |
| K920742 | HYDRAJUST IV UROLOGICAL TABLE | Apr 27, 1992 | Substantially Equivalent |
| K912944 | CT 8000 DIGITAL INJECTION SYSTEM | Feb 4, 1992 | Substantially Equivalent |
| K913264 | HYDRAVIEW 1000 DIGITAL IMAGE PROCESS/STOR DEVICE | Nov 1, 1991 | Substantially Equivalent |
| K905789 | FRANKLIN 9000 WALL STAND | May 20, 1991 | Substantially Equivalent |
| K904147 | HUGH YOUNG II UROLOGICAL X-RAY SYSTEM | Dec 13, 1990 | Substantially Equivalent |
| K904145 | HYDRA VISION UROLOGICAL X-RAY SYSTEM | Dec 13, 1990 | Substantially Equivalent |