BAUMAN RIGID LARYNGOSCOPE— 510(k) K901680

Name: FDA 510(k) clearance K901680
Creator: U.S. Food and Drug Administration
Published: 1990-07-12

Substantially Equivalent

Palex Intl. SA

FDA 510(k) clearance K901680 for BAUMAN RIGID LARYNGOSCOPE, Substantially Equivalent on 1990-07-12. Applicant: Palex Intl. SA. Device class: 1.

Clearance details

Applicant: Palex Intl. SA
Product code: Code CCW
Device class: Class 1
Regulation: 21 CFR 868.5540
Advisory panel: Anesthesiology
Date received: 1990-04-12
Decision date: 1990-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Spain, ES

Download summary PDF View on FDA.gov ↗

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K121378 — AIRTRAQ SP AIRTRAQ AVANT2012-06-21
K063477 — NOVAMED MRI CONDITIONAL LARYNGOSCOPE SET2007-02-09

More clearances from Palex Intl. SA

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K905108 — CONTORNO(R), MODELS E AND ST1991-02-04
K904586 — PALEX IRRIGATION SET1990-12-28
K903224 — EPISENSOR1990-12-24
K902642 — CONTORNO (TM)1990-08-07

Adverse events under product code CCW

product code CCW

Death: 31
Injury: 136
Malfunction: 3,703
Other: 1
Total: 3,871

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.