DeviceClearance

Product code CAZ— Anesthesiology

CONTINUOUS EPIDURAL ANESTHESIA TRAY

Classification name
Anesthesia Conduction Kit
Device class
Class 2
Regulation
21 CFR 868.5140
Advisory panel
Anesthesiology
Total cleared
155
First cleared
Most recent

FDA classification definition

“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.”

— U.S. Food and Drug Administration, device classification record for product code CAZ under 21 CFR 868.5140, via openFDA

Market context for product code CAZ

FDA has cleared 155 devices under product code CAZ between 1976 and 2023, filed by 72 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code CAZ

Adverse events under product code CAZ

product code CAZ
Injury
145
Malfunction
942
Other
1
Total
1,088

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code CAZ

1–100 of 155

Data sourced from openFDA. This site is unofficial and independent of the FDA.