RCT-1, RCT-2, RCT-3 ARTHROGRAM TRAY— 510(k) K870417

Name: FDA 510(k) clearance K870417
Creator: U.S. Food and Drug Administration
Published: 1987-03-05

Substantially Equivalent

North Coast Medi-Tek

FDA 510(k) clearance K870417 for RCT-1, RCT-2, RCT-3 ARTHROGRAM TRAY, Substantially Equivalent on 1987-03-05. Applicant: North Coast Medi-Tek. Device class: 1.

Clearance details

Applicant: North Coast Medi-Tek
Product code: Code FSM
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1987-02-03
Decision date: 1987-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mentor, OH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FSM

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K971217 — INSTRUMENT TRAY LINER1997-05-06
K962328 — SINGLE USE INSTRUMENT TRAY1996-08-09
K944025 — SURGICAL INSTRUMENT TRAY1994-11-22
K912106 — ARTHROSCOPY TRAY1991-08-29
K912053 — OPEN HEART TRAY1991-08-26

More clearances from North Coast Medi-Tek

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K870419 — IVR-SP CUSTOM ANGIOGRAPHY TRAY1987-05-11
K870420 — PTC-6 AND PTC-8 PERCUTANEOUS CHOLANGIOGRAPHY1987-04-14
K870416 — LP EXTENSION SETS1987-04-06
K870418 — MYA-1 AND MYT-1 MYELOGRAM TRAY1987-03-17
K854095 — BIOPSY TRAY I & II1985-11-25

Adverse events under product code FSM

product code FSM

Malfunction: 1,289
Total: 1,289

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.