APEX SUCTION CURETTE— 510(k) K871384

Name: FDA 510(k) clearance K871384
Creator: U.S. Food and Drug Administration
Published: 1987-05-22

Substantially Equivalent

Apex Medical, Inc.

FDA 510(k) clearance K871384 for APEX SUCTION CURETTE, Substantially Equivalent on 1987-05-22. Applicant: Apex Medical, Inc.. Device class: 1.

Clearance details

Applicant: Apex Medical, Inc.
Product code: Code GEA
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1987-04-07
Decision date: 1987-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Martinsville, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GEA

view all

K003965 — MRI SAFE INSTRUMENTS2001-03-16
K982472 — GENICON TROCAR1999-02-04
K954599 — CONMED TROGARD ELECTRONIC TROCAR SYSTEM1995-11-27
K922460 — ORIGIN SECONDARY CANNULA AND TROCAR1992-09-16
K920110 — ENDOPATH DISPOSABLE THORACIC TROCAR SLEEVE1992-04-02

More clearances from Apex Medical, Inc.

view all

K933965 — APEX MEDICAL AIR PUMPS1994-03-17
K902102 — COM-TENS: A NEUROSTIMULATOR1991-05-30
K882816 — PULSAR EM1989-04-27
K882468 — ELIMINATOR AIR FILTER1988-08-29
K871570 — APEX ALPHA VACUUM PUMP1987-08-18

Adverse events under product code GEA

product code GEA

Malfunction: 587
Total: 587

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.