REFLEX(TM) CLIP APPLIER— 510(k) K862404

Name: FDA 510(k) clearance K862404
Creator: U.S. Food and Drug Administration
Published: 1986-07-23

Substantially Equivalent

Richard-Allan Medical Ind., Inc.

FDA 510(k) clearance K862404 for REFLEX(TM) CLIP APPLIER, Substantially Equivalent on 1986-07-23. Applicant: Richard-Allan Medical Ind., Inc.. Device class: 2.

Clearance details

Applicant: Richard-Allan Medical Ind., Inc.
Product code: Code FZP
Device class: Class 2
Regulation: 21 CFR 878.4300
Advisory panel: General, Plastic Surgery
Date received: 1986-06-25
Decision date: 1986-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richland, MI, US

Download summary PDF View on FDA.gov ↗

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More clearances from Richard-Allan Medical Ind., Inc.

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K931879 — REFLEX HTR1994-03-24
K924200 — REFLEX(R) ESC1994-02-22
K926297 — REFLEX ESI1993-10-15
K924761 — STERILE ENDOSCOPIC DISPOS TROCARS W/SAFE SHIELD1993-04-20
K900566 — RICHARD-ALLAN VESSEL LOOPS1990-05-03

Adverse events under product code FZP

product code FZP

Death: 11
Injury: 726
Malfunction: 10,830
Other: 1
Total: 11,568

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.