CAPSULAR SHRINKAGE ELECTRODE— 510(k) K991830

Substantially Equivalent

Linvatec Corp.

FDA 510(k) clearance K991830 for CAPSULAR SHRINKAGE ELECTRODE, Substantially Equivalent on 1999-08-20. Applicant: Linvatec Corp.. Device class: 2.

Clearance details

Applicant: Linvatec Corp.
Product code: Code JOS
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 1999-05-28
Decision date: 1999-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Largo, FL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Linvatec Corp.

Recalls naming K991830

K-number listed on FDA's recall record

Z-0085-2017 — CONCEPT HEATWAVE Electrode 130 mm x 2.3 mm diameter, REF/Catalog Number CS-023, STERILE, Rx Only Product Usage: The HeatWave Electrode is intended to be used for electro-coagulation of soft tissue in shoulder, ankle, wrist, elbow and knee arthroscopic procedures.Class II·Terminated·ConMed Corporation·20160829

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K991830.

Data sourced from openFDA. This site is unofficial and independent of the FDA.