REGANES DISPOSABLE EPIDURAL ANESTHESIA TRAY— 510(k) K880181

Name: FDA 510(k) clearance K880181
Creator: U.S. Food and Drug Administration
Published: 1988-02-11

Substantially Equivalent

Reganes, Inc.

FDA 510(k) clearance K880181 for REGANES DISPOSABLE EPIDURAL ANESTHESIA TRAY, Substantially Equivalent on 1988-02-11. Applicant: Reganes, Inc.. Device class: 2.

Clearance details

Applicant: Reganes, Inc.
Product code: Code CAZ
Device class: Class 2
Regulation: 21 CFR 868.5140
Advisory panel: Anesthesiology
Date received: 1988-01-15
Decision date: 1988-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clearwater, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CAZ

view all

K222341 — Arrow 0.2 Micron Flat Filter, GVS2023-02-13
K210983 — BD Epilor Syringe2022-05-19
K201356 — Plastic LOR Syringe2021-02-12
K202699 — E-Cath STIM acc. Tsui2020-12-29
K190345 — VPC2019-05-16

More clearances from Reganes, Inc.

view all

K854816 — EPIDURAL ANESTHESIA NEEDLES1985-12-19

Adverse events under product code CAZ

product code CAZ

Injury: 145
Malfunction: 942
Other: 1
Total: 1,088

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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