OJRClass II

Vacuum Powered Body Fluid Collection Kit

General, Plastic Surgery · 21 CFR 878.4780

This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

MDR events18All time

Recalls1All time

Registered firms12Currently listed

510(k) clearances0All time

Recent MDR events

18 adverse event reports on file

Event type breakdown

Malfunction18

Most-reported manufacturers

Hologic, Inc.17 Cardinal Health 200, Llc1

Recalls

1 recall events for this product code

Thermedx LLC
TerminatedAug 27, 2014
The Thermedx Fluid Management System is designed to provide irrigation fluids to irrigate, distend, and debride while warming the fluid to assist in the prevent
A vendor changed the manufacturing process of a component used in the canister ring that may affect the performance of the ring. The deficit display may be higher than the actual deficit when the fluid collection canister is fully loaded.
Z-2555-2014 · View FDA record ↗

Registered firms

12 firms currently registered for this product code

510(k) clearances

0 clearances for this product code

No 510(k) clearances on file for this product code.