Advincula Delineator Uterine Manipulator— 510(k) K180429

Clearance details

Applicant

CooperSurgical, Inc.

Product code

Code HEW

Device class

Class 2

Regulation

21 CFR 884.1640

Advisory panel

Obstetrics/Gynecology

Date received

2018-02-16

Decision date

2018-03-14

Decision

Substantially Equivalent

Clearance type

Special

Location

Trumbull, CT, US

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• Z-1977-2019 — Advincula Delineator with Ultem Plastic Soft Cup size 2.5 cm; Part No. AD750SC-KE25 The Advincula Delineator Uterine Manipulator is a single-use disposable device designed specifically for Total Laparoscopic Hysterectomy (TLH), Laparoscopic Assisted Vaginal Hysterectomy (LAVH), and/or Laparoscopic Supra-Cervical Hysterectomy (LSCH).Class II·Terminated·CooperSurgical, Inc.·20190614
• Z-1978-2019 — Advincula Delineator with Ultem Plastic Soft Cup size 3.0 cm; Part No. AD750SC-KE30 The Advincula Delineator Uterine Manipulator is a single-use disposable device designed specifically for Total Laparoscopic Hysterectomy (TLH), Laparoscopic Assisted Vaginal Hysterectomy (LAVH), and/or Laparoscopic Supra-Cervical Hysterectomy (LSCH).Class II·Terminated·CooperSurgical, Inc.·20190614

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K180429.