AESCULAP HILAN MOTOR SYSTEM— 510(k) K980686

Name: FDA 510(k) clearance K980686
Creator: U.S. Food and Drug Administration
Published: 1998-09-02

Substantially Equivalent

Aesculap, Inc.

FDA 510(k) clearance K980686 for AESCULAP HILAN MOTOR SYSTEM, Substantially Equivalent on 1998-09-02. Applicant: Aesculap, Inc.. Device class: 2.

Clearance details

Applicant: Aesculap, Inc.
Product code: Code HBB
Device class: Class 2
Regulation: 21 CFR 882.4370
Advisory panel: Neurology
Date received: 1998-02-23
Decision date: 1998-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HBB

product code HBB

Malfunction: 2,656
Total: 2,656

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.