Product code FPY— General Hospital
TEMPORARY BURN SHEET WITH PERFORATED
- Classification name
- Sheet, Burn
- Device class
- Class 1
- Regulation
- 21 CFR 880.5180
- Advisory panel
- General Hospital
- Total cleared
- 17
- First cleared
- Most recent
Market context for product code FPY
FDA has cleared devices under product code FPY between 1976 and 1994, filed by 13 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 1994
- 1993
- 1990
- 1987
- 1985
- 1984
- 1982
- 1980
- 1979
- 1978
- 1976
Top applicants under product code FPY
Recent clearances under product code FPY
- K930759 — CP & S STERILE BURN SHEET
- K921470 — BURNSHIELD FIRE BLANKET
- K921471 — BURNSHIELD TRAUMA DRESSING
- K926290 — BURN SHEET
- K900441 — BURNS CASUALTY SHEET
- K900442 — BURNS CASUALTY SHEET BURN ROLL
- K900443 — BURNS CASUALTY SHEET LIMB WRAP
- K871740 — LYOSHEET SURGICAL SHEET FOR BURNS
- K853145 — KENDALL CURITY BURN PAD
- K841898 — FIRST RESPONSE EMERG. MEDICSL - BURNS
- K820994 — ABSORB FURN SHEET
- K800064 — WATER JEL FIRE BLANKET
- K792432 — TEMPORARY BURN SHEET WITH PERFORATED
- K792433 — TEMPORARY BURN SHEET WITH PERFORATED
- K780418 — BURN DRESSING PAD
- K760210 — BLANKET, WATER-JEL FIRE
- K760365 — BLANKET, BURN
Data sourced from openFDA. This site is unofficial and independent of the FDA.