Cleared Traditional

K140272 - SWIFT-LOCK ANCHOR

K140272 is an FDA 510(k) clearance for SWIFT-LOCK ANCHOR, manufactured by St Jude Medical. The device is a Class 2 Neurology device with product code GZB cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K140272 · St Jude Medical · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
88d
Days
Class 2
Risk

K140272 is an FDA 510(k) clearance for the SWIFT-LOCK ANCHOR. Classified as Stimulator, Spinal-cord, Implanted (pain Relief) (product code GZB), Class II - Special Controls.

Submitted by St Jude Medical (Plano, US). The FDA issued a Cleared decision on May 2, 2014 after a review of 88 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all St Jude Medical devices

FDA 510(k) Submission Details - K140272

510(k) Number K140272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2014
Decision Date May 02, 2014
Days to Decision 88 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
60d faster than avg
Panel avg: 148d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GZB Device Classification - Class 2, Special Controls

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 117
Devices cleared under the same product code (GZB) and FDA review panel - the closest regulatory comparables to K140272.
A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (1) plus Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (2), A.I.M. Lead Loop Suturing Device plus Tension Assist/Suture Cutter Device
K150924 · Anchor Innovation Medical (A.I.M.) · Jul 2015
Freedom Spinal Cord Stimulator System
K150517 · Stimwave Technologies Incorporated · Jun 2015
FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM
K141399 · Stimwave Technologies Incorporated · Oct 2014
MULTI LEAD TRIAL CABLE
K130545 · St Jude Medical · Jun 2013
MTS SYSTEM, WIDE-SPACE QUATTRODE PERCUTANEOUS LEADS
K123299 · St. Jude Medical Neuromodulation · Jan 2013
RAPID PROGRAMMER
K113611 · St Jude Medical · Apr 2012