NeuGuide— 510(k) K160569

Substantially Equivalent

Pop Medical Solutions

FDA 510(k) clearance K160569 for NeuGuide, Substantially Equivalent on 2016-07-06. Applicant: Pop Medical Solutions. Device class: 2.

Clearance details

Applicant: Pop Medical Solutions
Product code: Code PBQ
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 2016-02-29
Decision date: 2016-07-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tel Aviv, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code PBQ

K260380 — Mendit2026-03-04
K230730 — Apyx2023-07-25
K220420 — Saffron Fixation System2022-06-10
K213783 — Apyx2022-04-05
K130059 — ENDOFAST RELIANT SCP, ENDOFAST RELIANT LAP2013-07-29

Recalls naming K160569

K-number listed on FDA's recall record

Z-0556-2022 — The EnPlace is a single use trans-vaginal pelvic floor repair system which enables delivery of a tissue anchor to the ligaments of the vaginal cavity. The anchors are pre-loaded inside the device shaft and are ready for use. A thimble is also supplied, as an accessory for the device, to be used as a guide channel for better handling of the EnPlace. Intended Use / Indications for Use: The EnPlace system is intended for attaching sutures to ligaments of the pelvic floor.Class II·Ongoing·FEMSelect Ltd·20211213

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K160569.

Data sourced from openFDA. This site is unofficial and independent of the FDA.