KARL STORZ ENT SHAVER— 510(k) K953370

Name: FDA 510(k) clearance K953370
Creator: U.S. Food and Drug Administration
Published: 1995-09-06

Substantially Equivalent

KARL STORZ Endoscopy-America, Inc.

FDA 510(k) clearance K953370 for KARL STORZ ENT SHAVER, Substantially Equivalent on 1995-09-06. Applicant: KARL STORZ Endoscopy-America, Inc.. Device class: 1.

Clearance details

Applicant: KARL STORZ Endoscopy-America, Inc.
Product code: Code EQJ
Device class: Class 1
Regulation: 21 CFR 874.4140
Advisory panel: Ear, Nose, Throat
Date received: 1995-07-18
Decision date: 1995-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Culver City, CA, US

Download summary PDF View on FDA.gov ↗

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K230359 — KOH Ultramicro Injection Cannula (26167NN) +11 more2023-06-23
K223520 — UNIDRIVE SIII System2023-04-27

Adverse events under product code EQJ

product code EQJ

Malfunction: 1,552
Total: 1,552

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.