THE CART— 510(k) K872533

Name: FDA 510(k) clearance K872533
Creator: U.S. Food and Drug Administration
Published: 1987-11-02

Substantially Equivalent

Arthropedics, Inc.

FDA 510(k) clearance K872533 for THE CART, Substantially Equivalent on 1987-11-02. Applicant: Arthropedics, Inc.. Device class: 2.

Clearance details

Applicant: Arthropedics, Inc.
Product code: Code HRX
Device class: Class 2
Regulation: 21 CFR 888.1100
Advisory panel: Orthopedic
Date received: 1987-06-26
Decision date: 1987-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wallington, NJ, US

Download summary PDF View on FDA.gov ↗

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More clearances from Arthropedics, Inc.

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K873619 — ARTHROSCOPIC RETENTION-MANIPULATION SYSTEM (ARMS)1988-01-14
K873653 — MONOPOLAR CAUTERY BLADE TIP #TM-17011987-12-15
K873654 — MONOPOLAR CAUTERY CONICAL TIP #TM-17021987-12-15
K873655 — MONOPOLAR CAUTERY RETROGADE TIP #TM-17031987-12-15
K873387 — VIDEO ARTHROSCOPE, 1.7MM X 55 MM1987-11-25

Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

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.