SILIMED CALF IMPLANT— 510(k) K974480

Name: FDA 510(k) clearance K974480
Creator: U.S. Food and Drug Administration
Published: 1998-02-24

Substantially Equivalent

Silimed, LLC

FDA 510(k) clearance K974480 for SILIMED CALF IMPLANT, Substantially Equivalent on 1998-02-24. Applicant: Silimed, LLC. Device class: 2.

Clearance details

Applicant: Silimed, LLC
Product code: Code MIB
Device class: Class 2
Regulation: 21 CFR 874.3620
Advisory panel: Ear, Nose, Throat
Date received: 1997-11-26
Decision date: 1998-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crofton, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MIB

view all

K241150 — MISTI Silicone Implant2024-07-24
K223051 — Pre-Formed Silicone Block2023-02-03
K222748 — ShiNeo Silicone Implant2022-12-23
K200073 — AugMENTA Penile Implant2022-09-30
K220760 — Pre-Formed Penile Silicone Block2022-05-13

More clearances from Silimed, LLC

view all

K974479 — SILIMED VAGINAL STENT1998-08-05
K981852 — SILIMED TISSUE EXPANDER1998-08-05
K981835 — SILIMED MALAR IMPLANT1998-07-09
K981850 — SILIMED CHIN IMPLANTS1998-07-09
K981851 — SILIMED SILICONE CARVING BLOCK1998-07-09

Adverse events under product code MIB

product code MIB

Injury: 146
Total: 146

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.