Cleared Traditional

K932202 - MODEL 3862A & B 3863A & B TEMP. LEAD SC...

K932202 is the FDA 510(k) clearance for MODEL 3862A & B 3863A & B TEMP. LEAD SC... by Medtronic Vascular. It is a Class 2 Neurology device (product code GZB) cleared through the Traditional 510(k) pathway after a 363-day FDA review.

K932202 · Medtronic Vascular · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1994
Decision
363d
Days
Class 2
Risk

K932202 is an FDA 510(k) clearance for the MODEL 3862A & B 3863A & B TEMP. LEAD SCREENING KIT. Classified as Stimulator, Spinal-cord, Implanted (pain Relief) (product code GZB), Class II - Special Controls.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on May 4, 1994 after a review of 363 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5880 - 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 Medtronic Vascular devices

Submission Details

510(k) Number K932202 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 1993
Decision Date May 04, 1994
Days to Decision 363 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
215d slower than avg
Panel avg: 148d · This submission: 363d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GZB Stimulator, Spinal-cord, Implanted (pain Relief)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5880
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 - GZB Stimulator, Spinal-cord, Implanted (pain Relief)

All 74
Devices cleared under the same product code (GZB) and FDA review panel - the closest regulatory comparables to K932202.
NEUROLOGICAL LEADS (PACKAGING MODIFICATION)
K940416 · Medtronic Vascular · Jul 1994
NEUROLOGICAL LEAD ACCESSORIES
K936099 · Medtronic Vascular · Jul 1994
TEMPORARY SCREENING LEAD/CATHETER KIT
K934938 · Medtronic Vascular · Jun 1994
MEDTRONIC MODEL 3625 SCREENER SYSTEM
K932948 · Medtronic Vascular · Feb 1994
MEDTRONIC MODEL 3487A PISCES-QUAD LEAD
K923931 · Medtronic Vascular · Mar 1993
MEDTRONIC MODEL 3080 PISCES-QUAD LEAD
K924522 · Medtronic Vascular · Mar 1993