MICROFLEX— 510(k) K942304

Name: FDA 510(k) clearance K942304
Creator: U.S. Food and Drug Administration
Published: 1994-06-13

Substantially Equivalent

Moeller Microsurgical, Inc.

FDA 510(k) clearance K942304 for MICROFLEX, Substantially Equivalent on 1994-06-13. Applicant: Moeller Microsurgical, Inc.. Device class: 1.

Clearance details

Applicant: Moeller Microsurgical, Inc.
Product code: Code FSO
Device class: Class 1
Regulation: 21 CFR 878.4700
Advisory panel: General, Plastic Surgery
Date received: 1994-05-13
Decision date: 1994-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waldwick, NJ, US

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Recent devices under product code FSO

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K941399 — OPERATING MICROSCOPE AA OM 101994-04-22
K920689 — DEEMED MSS -- MICROSCOPE SUPPORT SYSTEM1993-11-12
K926288 — SOM 6VI (SURGICAL OPERATING MICROSCOPE)1993-10-12
K931303 — WOODLYN OPERATION MICROSCOPE1993-06-25
K926513 — MOLLER-WEDEL OPERATING MICROSCOPE1993-06-22

Adverse events under product code FSO

product code FSO

Other: 1
Total: 1

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.