INJECT-EASE— 510(k) K872233

Name: FDA 510(k) clearance K872233
Creator: U.S. Food and Drug Administration
Published: 1987-09-04

Substantially Equivalent

Palco Laboratories, Inc.

FDA 510(k) clearance K872233 for INJECT-EASE, Substantially Equivalent on 1987-09-04. Applicant: Palco Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Palco Laboratories, Inc.
Product code: Code KZH
Device class: Class 2
Regulation: 21 CFR 880.6920
Advisory panel: General Hospital
Date received: 1987-06-10
Decision date: 1987-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Cruz, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KZH

view all

K243232 — GripMate2024-12-02
K213429 — AccuSert Needle Inserter2022-10-20
K163400 — Orbit Inserter2017-07-26
K160860 — MiniMed Quick-serter2016-09-22
K141384 — WHISPERJECT AUTOINJECTOR2014-09-12

More clearances from Palco Laboratories, Inc.

view all

K942810 — PALCO LABS COLD POUCH1995-06-28
K943842 — PULSE OXIMETER MODEL 3051995-03-24
K920066 — PALCO LABS MODEL 340 PULSE OXIMETER1993-03-16
K913694 — PALCO LABS LOADMATIC1991-12-17
K911191 — PALCO LABS MODEL 300 OXYGEN/PULSE MONITOR1991-06-10

Adverse events under product code KZH

product code KZH

Other: 1
Total: 1

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.