Cleared Traditional

K001353 - MEMOGRAPH

Also marketed or referenced as:
OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEM

K001353 is an FDA 510(k) clearance for MEMOGRAPH, manufactured by Biomedical Ent., Inc.. The device is a Class 2 Neurology device with product code HBW cleared through the Traditional 510(k) pathway after a 319-day FDA review.

K001353 · Biomedical Ent., Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2001
Decision
319d
Days
Class 2
Risk

K001353 is an FDA 510(k) clearance for the MEMOGRAPH. Classified as Fastener, Plate, Cranioplasty (product code HBW), Class II - Special Controls.

Submitted by Biomedical Ent., Inc. (San Antonio, US). The FDA issued a Cleared decision on March 13, 2001 after a review of 319 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5360 - 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. Elevated predicate reliance profile. 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 Biomedical Ent., Inc. devices

FDA 510(k) Submission Details - K001353

510(k) Number K001353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2000
Decision Date March 13, 2001
Days to Decision 319 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
171d slower than avg
Panel avg: 148d · This submission: 319d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HBW Device Classification - Class 2, Special Controls

Product Code HBW Fastener, Plate, Cranioplasty
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5360
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.