INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX— 510(k) K983200

Name: FDA 510(k) clearance K983200
Creator: U.S. Food and Drug Administration
Published: 1998-12-11

Substantially Equivalent

Ximed/Prosure/Injectx

FDA 510(k) clearance K983200 for INJECTION/ASPIRATION NEEDLES PROBES/DEVICES-TPI/TPI FLEX, Substantially Equivalent on 1998-12-11. Applicant: Ximed/Prosure/Injectx. Device class: 1.

Clearance details

Applicant: Ximed/Prosure/Injectx
Product code: Code GAA
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1998-09-14
Decision date: 1998-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

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K002269 — ELECTROSURGICAL PROBES AND DEVICES-GELTX2001-01-04
K983765 — INJECTION NEEDLE PROBE/DEVICE-TUNIS1998-12-11
K981256 — ISOLATED SALINE ELECTRODES/PROBES/DEVICES-SALINETRODE1998-05-12
K974484 — ISOLATED ELECTROSURGICAL PROBES AND DEVICES-SALINETRODE1998-02-10
K974637 — ELECTRODES/PROBES/DEVICES1998-01-07

Adverse events under product code GAA

product code GAA

Malfunction: 834
Total: 834

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.