Cleared Traditional

K160569 - NeuGuide

K160569 is an FDA 510(k) clearance for NeuGuide, manufactured by Pop Medical Solutions. The device is a Class 2 Obstetrics & Gynecology device with product code PBQ cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K160569 · Pop Medical Solutions · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2016
Decision
128d
Days
Class 2
Risk

K160569 is an FDA 510(k) clearance for the NeuGuide. Classified as Fixation, Non-absorbable Or Absorbable, For Pelvic Use (product code PBQ), Class II - Special Controls.

Submitted by Pop Medical Solutions (Tel Aviv, IL). The FDA issued a Cleared decision on July 6, 2016 after a review of 128 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - the FDA obstetrics and gynecology 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 Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K160569

510(k) Number K160569 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 29, 2016
Decision Date July 06, 2016
Days to Decision 128 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 161d · This submission: 128d
Pathway characteristics
Predicate-based equivalence.

PBQ Device Classification - Class 2, Special Controls

Product Code PBQ Fixation, Non-absorbable Or Absorbable, For Pelvic Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4530
Definition Attaching Suture Or Stapling Ligaments Of The Pelvic Floor.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Obstetrics & Gynecology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02190825 Completed Interventional Industry-sponsored

Safety and Efficacy Study of the NeuGuide Device

15
Patients (actual)
2
Sites
Treatment
Purpose
Open label
Masking
Condition studied Pelvic Organ Prolapse
Study design Single group
Eligibility Female only · 18 Years+
Sponsor Pop Medical Solutions (industry)
Started 2014-11-01 → Primary completion 2016-04-01 → Completed 2023-10-30
Primary outcome
Stage of pelvic floor prolapse as defined by POP-Q score
Study completed - no results published. This trial concluded in 2023 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - PBQ Fixation, Non-absorbable Or Absorbable, For Pelvic Use

All 7
Devices cleared under the same product code (PBQ) and FDA review panel - the closest regulatory comparables to K160569.
Apyx
K230730 · Escala Medical · Jul 2023
Saffron Fixation System
K220420 · Coloplast A/S · Jun 2022
Apyx
K213783 · Escala Medical · Apr 2022
ENDOFAST RELIANT SCP, ENDOFAST RELIANT LAP
K130059 · Ibi Israel Biomedical Innovations , Ltd. · Jul 2013
ANCHORSURE
K120831 · Neomedic International S.L. · Oct 2012
GYNECARE PROLENE FASTENER SYSTEM
K042603 · Ethicon, Inc. · Dec 2004
K160569 · NeuGuide
Download PDF FDA Summary Pop Medical Solutions