BALLOON ELECTROSURGICAL PROBES AND DEVICES— 510(k) K943014

Name: FDA 510(k) clearance K943014
Creator: U.S. Food and Drug Administration
Published: 1996-03-11

Substantially Equivalent

Ximed Medical Systems

FDA 510(k) clearance K943014 for BALLOON ELECTROSURGICAL PROBES AND DEVICES, Substantially Equivalent on 1996-03-11. Applicant: Ximed Medical Systems. Device class: 2.

Clearance details

Applicant: Ximed Medical Systems
Product code: Code GEI
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 1994-06-24
Decision date: 1996-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Ximed Medical Systems

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K946377 — ELECTROPROBE SINGLE USE ELECTROSURGICAL PROBES1995-03-24
K933757 — HAND-HELD IRRIGATION PUMP1994-08-26
K933458 — SURGICAL TROCARS1994-05-05
K922714 — UNIVERSAL IRRIGATION & SUCTION TUBING SET1993-08-03
K922523 — BIPOLAR ELECTROSURGICAL PROBES & INSTRUMENTS1992-09-23

Adverse events under product code GEI

product code GEI

Death: 133
Injury: 7,585
Malfunction: 35,808
Other: 44
Total: 43,570

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.