FYF — Cap, Surgical Class I
FDA product code FYF covers "Cap, Surgical", a Class I medical device regulated under 21 CFR 878.4040. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- FYF
- Device Class
- Class I
- Regulation Number
- 878.4040
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K972227 | american seal | SHOE COVER | September 9, 1997 |
| K955833 | amerasia | NIOMED SURGICAL CAPS | March 15, 1996 |
| K954556 | thai disposable products co | SURGICAL CAP | March 12, 1996 |
| K954454 | amerasia | NIOMED SURGICAL HOOD | January 23, 1996 |
| K954455 | amerasia | NIOMED BOUFFANT CAPS | January 23, 1996 |
| K953879 | american threshold industries | SURGEON'S CAP | January 5, 1996 |
| K953878 | american threshold industries | BOUFFANT CAP | January 5, 1996 |
| K913700 | gem nonwovews | DISPOSABLE BOUFFANT CAP | October 4, 1991 |
| K882346 | nordbye, milchman, barlage | INSTRUMENT PROTECT-A-CAPS, AKA: TIP/INSTRU. GUARD | June 30, 1988 |
| K882284 | a plus international | SURGEONS CAP | June 23, 1988 |
| K882283 | a plus international | BOUFFANT CAP | June 23, 1988 |
| K880481 | james river | CARETEX SURGEON'S CAPS | February 24, 1988 |
| K875261 | kimberly-clark | KIMBERLY-CLARK FULL COVERAGE HOOD | January 22, 1988 |
| K874066 | interpro intl | SURGICAL CAPS | November 4, 1987 |
| K873830 | tecnol new jersey wound care | TECNOL SURGEON'S CAP | October 23, 1987 |
| K870618 | kin yuh hung co | VARIOUS TYPES OF SURGICAL GARMENTS | March 9, 1987 |
| K870617 | greene international | VARIOUS TYES OF SURGICAL GARMENTS | March 9, 1987 |
| K863359 | kimberly-clark | BOUFFANT-STYLE SURGICAL CAP | September 29, 1986 |
| K851558 | roseburg | SURGICAL CAP CALOT | April 30, 1985 |
| K844704 | medicon | CAPS (O.R. NURSE, SURGICAL) | January 10, 1985 |