REICHERT FLEXIBLE LARYNGOSCOPE, MODEL LS-11— 510(k) K852994

Name: FDA 510(k) clearance K852994
Creator: U.S. Food and Drug Administration
Published: 1985-07-29

Substantially Equivalent

Reichert-Jung, Inc.

FDA 510(k) clearance K852994 for REICHERT FLEXIBLE LARYNGOSCOPE, MODEL LS-11, Substantially Equivalent on 1985-07-29. Applicant: Reichert-Jung, Inc.. Device class: 1.

Clearance details

Applicant: Reichert-Jung, Inc.
Product code: Code CAL
Device class: Class 1
Regulation: 21 CFR 868.5530
Advisory panel: Anesthesiology
Date received: 1985-07-15
Decision date: 1985-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Southbridge, MA, US

Download summary PDF View on FDA.gov ↗

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K951194 — FI-10M1995-04-06
K951195 — FI-10P1995-04-06
K872895 — HAEMONETICS CELL SAVER MINI SAVER AUTO. BLOOD SYS.1988-01-11
K850978 — OLYMPUS LF-1 INTUBATION SCOPE1985-05-23
K802331 — AO FLEXIBLE LARYNGOSCOPE, #LS-71980-10-10

More clearances from Reichert-Jung, Inc.

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K864821 — AIRWAY FIBERSCOPES, MODELS LS-9, 0L-1, 0L-2 & PL-21987-02-10
K862551 — FUNS-10, FUNS-111986-09-12

Adverse events under product code CAL

product code CAL

Malfunction: 885
Total: 885

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.