IRRIGATION/ASPIRATION NEEDLE— 510(k) K771416

Name: FDA 510(k) clearance K771416
Creator: U.S. Food and Drug Administration
Published: 1977-09-12

Substantially Equivalent

Concept, Inc.

FDA 510(k) clearance K771416 for IRRIGATION/ASPIRATION NEEDLE, Substantially Equivalent on 1977-09-12. Applicant: Concept, Inc.. Device class: 1.

Clearance details

Applicant: Concept, Inc.
Product code: Code HMX
Device class: Class 1
Regulation: 21 CFR 886.4350
Advisory panel: Ophthalmic
Date received: 1977-08-01
Decision date: 1977-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HMX

view all

K010305 — WEISS RETINAL CANNULA2001-05-02
K000457 — VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES2000-05-09
K970873 — ENDOSOFT SOFT TIP NEEDLE (20 GA. AND 19 GA.)1997-05-20
K943932 — STERISEAL OPHTHALMIC CANNULA1995-01-18
K942403 — INFUSION CANNULA1994-08-17

More clearances from Concept, Inc.

view all

K912640 — CONCEPT ENDOSTEAL FIXATION DEVICE1992-05-01
K912957 — CONCEPT MICROMILL1991-10-04
K896648 — CONCEPT UNICOMPARTMENTAL KNEE SYSTEM1990-06-05
K894929 — STAPLE FIXATION SYSTEM1989-08-30
K892376 — INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.)1989-08-01

Adverse events under product code HMX

product code HMX

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.