Cleared Traditional

K980548 - DURA-PATCH MODEL DP-XXX

K980548 is an FDA 510(k) clearance for DURA-PATCH MODEL DP-XXX, manufactured by Bridger Biomed, Inc.. The device is a Class 2 Neurology device with product code GXQ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K980548 · Bridger Biomed, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
90d
Days
Class 2
Risk

K980548 is an FDA 510(k) clearance for the DURA-PATCH MODEL DP-XXX. Classified as Dura Substitute (product code GXQ), Class II - Special Controls.

Submitted by Bridger Biomed, Inc. (Bozeman, US). The FDA issued a Cleared decision on May 13, 1998 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5910 - 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 Bridger Biomed, Inc. devices

FDA 510(k) Submission Details - K980548

510(k) Number K980548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1998
Decision Date May 13, 1998
Days to Decision 90 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
58d faster than avg
Panel avg: 148d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXQ Device Classification - Class 2, Special Controls

Product Code GXQ Dura Substitute
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5910
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 - GXQ Dura Substitute

All 34
Devices cleared under the same product code (GXQ) and FDA review panel - the closest regulatory comparables to K980548.
DURAGEN DURAL GRAFT MATRIX
K982180 · Integra Lifesciences Corp. · Jul 1999
PRECLUDE ACUSEAL DURA SUBSTITUTE
K984534 · W.L. Gore & Associates, Inc. · Mar 1999
DURA-GUARD - DURAL REPAIR PATCH
K982282 · Bio-Vascular, Inc. · Jul 1998
DURA-GUARD-DURAL REPAIR PATCH
K973706 · Bio-Vascular, Inc. · Dec 1997
LYOPLANT DURA SUBSTITUTE(VARIOUS)
K970851 · Aesculap, Inc. · Dec 1997
NEURO-PATCH
K960470 · Aesculap, Inc. · May 1996