Cleared Traditional

K153243 - Fehling-Punches

K153243 is an FDA 510(k) clearance for Fehling-Punches, manufactured by Fehling Instruments GmbH & Co. KG. The device is a Class 2 Neurology device with product code HAE cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K153243 · Fehling Instruments GmbH & Co. KG · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
269d
Days
Class 2
Risk

K153243 is an FDA 510(k) clearance for the Fehling-Punches. Classified as Rongeur, Manual (product code HAE), Class II - Special Controls.

Submitted by Fehling Instruments GmbH & Co. KG (Karlstein, DE). The FDA issued a Cleared decision on August 4, 2016 after a review of 269 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4840 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K153243

510(k) Number K153243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 2015
Decision Date August 04, 2016
Days to Decision 269 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
120d slower than avg
Panel avg: 149d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HAE Device Classification - Class 2, Special Controls

Product Code HAE Rongeur, Manual
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4840
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Consultant

Visamed GmbH
Arne Briest

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HAE Rongeur, Manual

All 31
Devices cleared under the same product code (HAE) and FDA review panel - the closest regulatory comparables to K153243.
Ace Medical Surgical Instruments
K200387 · Ace Medical · Jul 2020
Steribite
K180949 · Rjr Surgical, Inc. · Nov 2018
Symmetry Sharp Kerrison Rongeur
K161744 · Symmetry Surgical, Inc. · Sep 2016
Kerrison Rongeurs
K152734 · Vitalitec Medizintechnik GmbH · Jun 2016
Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs
K150468 · K2 Medical GmbH & Co. KG · Feb 2016
Integra (R) Jarit (R) Kerrison Rongeurs, Integra (R) Ruggles (TM)-Redmons (TM) Kerrison Rongeurs, Integra (R) Miltex (R) Kerrison Rongeurs, Integra (R) Meisterhand (R) Kerrison Rongeurs
K150428 · Integra Lifesciences Corp. · Apr 2015