Bite Away— 510(k) K160943

Name: FDA 510(k) clearance K160943
Creator: U.S. Food and Drug Administration
Published: 2016-08-26

Substantially Equivalent

Riemser Pharma

FDA 510(k) clearance K160943 for Bite Away, Substantially Equivalent on 2016-08-26. Applicant: Riemser Pharma. Device class: 2.

Clearance details

Applicant: Riemser Pharma
Product code: Code IRT
Device class: Class 2
Regulation: 21 CFR 890.5740
Advisory panel: Physical Medicine
Date received: 2016-04-05
Decision date: 2016-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Greifswald-Insel Riems, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code IRT

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K250047 — bite away two2025-09-12
K220514 — bite away neo2022-06-23
K142228 — Heated Eye Pad2015-02-09
K133981 — AVACEN 1002014-08-15
K111273 — FIR HEAT THERAPHY SYSYEMS2011-11-08

Adverse events under product code IRT

product code IRT

Injury: 668
Total: 668

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.