FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SURGEON'S CAP
K Number: K953879
·
Decision Jan 5, 1996
Classifications
1
FEI Numbers
291
Registration Numbers
291
Same Product Code
31
Applicant Total
20
Review Days
142
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
- SURGEON'S CAP
- K Number
- K953879
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- American Threshold Industries, Inc.
- Date Received
- August 16, 1995
- Decision Date
- January 5, 1996
- Product Code
- FYF
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| FYF | Cap, Surgical | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FYF), ordered by most recent decision date.
SHOE COVER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NIOMED SURGICAL CAPS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SURGICAL CAP
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NIOMED SURGICAL HOOD
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NIOMED BOUFFANT CAPS
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
BOUFFANT CAP
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by American Threshold Industries, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K971483 | SECURE-WRAP (TM) STERILIZATION WRAP | Jun 24, 1997 | Substantially Equivalent |
| K953878 | BOUFFANT CAP | Jan 5, 1996 | Substantially Equivalent |
| K952114 | KOOL GARD SINGLES GOWN | Sep 25, 1995 | Substantially Equivalent |
| K952115 | BARRIER GOWN, KOOL-GARD BACKLESS GOWN | Sep 25, 1995 | Substantially Equivalent |
| K952116 | COVER GOWN | Sep 5, 1995 | Substantially Equivalent |
| K934085 | MODIFICATION OF SURGICAL EYESHIELD MASK | Nov 12, 1993 | Substantially Equivalent |
| K915530 | NOVA GAUZE(R) DISPOSABLE NONWOVEN SPONGES, STERILE | Aug 17, 1992 | Substantially Equivalent |
| K915740 | DISPOSABLE O.R. TOWEL, STERILE | Jun 22, 1992 | Substantially Equivalent |
| K912110 | DISPOSABLE O.R. TOWEL | Jul 25, 1991 | Substantially Equivalent |
| K894383 | DISPOSABLE SHOE COVER | Sep 12, 1989 | Substantially Equivalent |