Cleared Traditional

K993019 - PACIFIC SURGICAL PATTIES

K993019 is an FDA 510(k) clearance for PACIFIC SURGICAL PATTIES, manufactured by V. Mueller Neuro/Spine. The device is a Class 2 Neurology device with product code HBA cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K993019 · V. Mueller Neuro/Spine · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
204d
Days
Class 2
Risk

K993019 is an FDA 510(k) clearance for the PACIFIC SURGICAL PATTIES. Classified as Neurosurgical Paddie (product code HBA), Class II - Special Controls.

Submitted by V. Mueller Neuro/Spine (San Carlos, US). The FDA issued a Cleared decision on March 30, 2000 after a review of 204 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4700 - 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 - K993019

510(k) Number K993019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1999
Decision Date March 30, 2000
Days to Decision 204 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
55d slower than avg
Panel avg: 149d · This submission: 204d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HBA Device Classification - Class 2, Special Controls

Product Code HBA Neurosurgical Paddie
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4700
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 - HBA Neurosurgical Paddie

All 18
Devices cleared under the same product code (HBA) and FDA review panel - the closest regulatory comparables to K993019.
AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE)
K031008 · Aesculap · May 2003
TRAATEK COTTONOID PATTIES
K020736 · Traatek, Inc. · Jun 2002
NORAPAD PLAIN
K014268 · Perlei Medical, Inc. · Mar 2002
ULTRACELL NEURO SPONGES
K973083 · Ultracell Medical Technologies, Inc. · Dec 1997
AMERICAN SURGICAL SPONGES/NEUROSURGICAL SPONGES
K962807 · American Surgical Sponges · May 1997
ULTRACELL NEURO SPONGES
K970328 · Ultracell Medical Technologies, Inc. · Apr 1997
K993019 · PACIFIC SURGICAL PATTIES
Download PDF FDA Summary V. Mueller Neuro/Spine