SOM 6VI (SURGICAL OPERATING MICROSCOPE)— 510(k) K926288

Name: FDA 510(k) clearance K926288
Creator: U.S. Food and Drug Administration
Published: 1993-10-12

Substantially Equivalent

Jedmed Instrument Co.

FDA 510(k) clearance K926288 for SOM 6VI (SURGICAL OPERATING MICROSCOPE), Substantially Equivalent on 1993-10-12. Applicant: Jedmed Instrument Co.. Device class: 1.

Clearance details

Applicant: Jedmed Instrument Co.
Product code: Code FSO
Device class: Class 1
Regulation: 21 CFR 878.4700
Advisory panel: General, Plastic Surgery
Date received: 1992-12-14
Decision date: 1993-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St.Louis, MO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FSO

view all

K942304 — MICROFLEX1994-06-13
K941399 — OPERATING MICROSCOPE AA OM 101994-04-22
K920689 — DEEMED MSS -- MICROSCOPE SUPPORT SYSTEM1993-11-12
K931303 — WOODLYN OPERATION MICROSCOPE1993-06-25
K926513 — MOLLER-WEDEL OPERATING MICROSCOPE1993-06-22

More clearances from Jedmed Instrument Co.

view all

K132039 — ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM2014-02-21
K021750 — LID CHAIN EYELID WEIGHTS2003-01-27
K954184 — JED-LIGHT FIBEROPTIC LIGHT SOURCE1995-11-13
K944032 — VIDEO SCOPE SYSTEM (LARYNGOSCOPE)1995-09-15
K950925 — JEDMED LARYNGEAL SCOPE1995-08-11

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.