Product code JDY— Orthopedic
BIOVAC: LFA LASER FUME (SMOKE) EVACUATIO
- Classification name
- Evacuator, Vapor, Cement Monomer
- Device class
- Class 1
- Regulation
- 21 CFR 888.4220
- Advisory panel
- Orthopedic
- Total cleared
- 8
- First cleared
- Most recent
Market context for product code JDY
FDA has cleared devices under product code JDY between 1976 and 1991, filed by 7 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
- 1991
- 1990
- 1986
- 1981
- 1979
- 1978
- 1977
- 1976
Top applicants under product code JDY
Recent clearances under product code JDY
- K902167 — CONTAIN(TM) LASER PLUME FILTER
- K902056 — LASER TRAP 100 LASER PLUME SMOKE EVACUATION FILTER
- K862509 — CHARCOAL LASER SMOKE FILTER CATALOG NO. 901103-000
- K810542 — CEMENT FUME EVACUATOR TANK & FILTER
- K790877 — BIOVAC: LFA LASER FUME (SMOKE) EVACUATIO
- K780202 — MONOMER EVACUATION SYSTEM
- K770690 — MASK, VAPOR, MONOMER
- K760906 — MONOMER VAPOR CONTAINMENT SYSTEM
Data sourced from openFDA. This site is unofficial and independent of the FDA.