RESTORELLE L— 510(k) K122440

Name: FDA 510(k) clearance K122440
Creator: U.S. Food and Drug Administration
Published: 2012-11-19

Substantially Equivalent

Coloplast Corp.

FDA 510(k) clearance K122440 for RESTORELLE L, Substantially Equivalent on 2012-11-19. Applicant: Coloplast Corp.. Device class: 2.

Clearance details

Applicant: Coloplast Corp.
Product code: Code OTO
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2012-08-10
Decision date: 2012-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

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K171271 — Polyform Synthetic Mesh2017-12-15
K150016 — Vertessa Lite2015-04-06
K150023 — Vertessa Lite Y-Mesh2015-04-06
K140116 — RESTORELLE Y CONTOUR MESH2014-02-12
K132061 — RESTORELLE M, RESTORELLE XL2013-08-02

More clearances from Coloplast Corp.

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Adverse events under product code OTO

product code OTO

Injury: 840
Total: 840

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 →

Recalls naming K122440

K-number listed on FDA's recall record

Z-1341-2013 — Rostorelle L, Polypropylene Mesh, Catalog number 501440, Manufacturer Coloplast A/S 3050 Denmark.Class II·Terminated·Coloplast Manufacturing US, LLC·20130412

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K122440.

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