Cleared Traditional

K901372 - LAMINECTOMY RONGEUR

K901372 is an FDA 510(k) clearance for LAMINECTOMY RONGEUR, manufactured by Zeppelin GmbH. The device is a Class 2 Neurology device with product code HAE cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K901372 · Zeppelin GmbH · Neurology device
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Jun 1990
Decision
98d
Days
Class 2
Risk

K901372 is an FDA 510(k) clearance for the LAMINECTOMY RONGEUR. Classified as Rongeur, Manual (product code HAE), Class II - Special Controls.

Submitted by Zeppelin GmbH (West Germany, DE). The FDA issued a Cleared decision on June 28, 1990 after a review of 98 days - within the typical 510(k) review window.

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.

View all Zeppelin GmbH devices

FDA 510(k) Submission Details - K901372

510(k) Number K901372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1990
Decision Date June 28, 1990
Days to Decision 98 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 148d · This submission: 98d
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 Peers - HAE Rongeur, Manual

All 26
Devices cleared under the same product code (HAE) and FDA review panel - the closest regulatory comparables to K901372.
ULTRA LOW PROFILE RONGEUR
K062711 · Baxano, Inc. · Mar 2007
BRAY RONGEUR
K954699 · Johnson & Johnson Professionals, Inc. · Dec 1995
AUTO SUTURE KERRISON SPINAL RONGEUR
K943116 · United States Surgical, A Division of Tyco Healthc · Jul 1994
NEUROLOGICAL RONGEURS - VARIOUS TYPES
K892535 · Zinnanti Surgical Instruments, Inc. · May 1989