COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-1— 510(k) K013243

Name: FDA 510(k) clearance K013243
Creator: U.S. Food and Drug Administration
Published: 2002-01-09

Substantially Equivalent

Bioform, Inc.

FDA 510(k) clearance K013243 for COAPTITE LARYNGEAL AUGMENTATION SYSTEM 1CC & O.5CC, MODELS 0008021-1, 0008022-1, Substantially Equivalent on 2002-01-09. Applicant: Bioform, Inc.. Device class: 2.

Clearance details

Applicant: Bioform, Inc.
Product code: Code KHJ
Device class: Class 2
Regulation: 21 CFR 874.3620
Advisory panel: Ear, Nose, Throat
Date received: 2001-09-28
Decision date: 2002-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franksville, WI, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K013243

K-number listed on FDA's recall record

Z-0368-2016 — PROLARYN PLUS Injectable Implant 1.0 cc Plus Calcium Hydroxlyapatite (CaHA) Injectable Implant, Model No. 8044M0K5. An injectable implant used to treat vocal fold insufficiency.Class II·Terminated·Merz North America, Inc.·20151026

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K013243.

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