KOH COLPOTOMIZER SYSTEM— 510(k) K954311

Substantially Equivalent

CooperSurgical, Inc.

FDA 510(k) clearance K954311 for KOH COLPOTOMIZER SYSTEM, Substantially Equivalent on 1996-11-19. Applicant: CooperSurgical, Inc.. Device class: 2.

Clearance details

Applicant: CooperSurgical, Inc.
Product code: Code HEW
Device class: Class 2
Regulation: 21 CFR 884.1640
Advisory panel: Obstetrics/Gynecology
Date received: 1995-09-15
Decision date: 1996-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HEW

K243152 — GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device2025-10-02
K201086 — Advincula Delineator Uterine Manipulator2020-05-21
K191294 — Transvaginal Access Platform2019-09-06
K180429 — Advincula Delineator Uterine Manipulator2018-03-14
K161065 — ColpoWave Colpotomizer and CerviGrip Uterine Manipulator2016-10-27

More clearances from CooperSurgical, Inc.

K261083 — Wallace® Aspiration Pump (WAPV1); Wallace® Pump Filter Connector (WFC); Wallace® Vacuum Connection Kit (WVCK)2026-08-19
K243799 — Fetal Pillow2025-08-29
K250438 — CooperSurgical Milex® Pessaries2025-04-11
K223064 — ALLY II Uterine Positioning System (UPS)2022-10-28
K200038 — Endosee System2020-02-05

Recalls naming K954311

K-number listed on FDA's recall record

Z-1686-2021 — The Ultem Polymeric Resin Koh Cup is a non- sterile, reusable vaginal fornices delineator. It is made of medical grade plastics and not made with natural rubber latex. Model Number(s): KCP-30-2Class II·Ongoing·CooperSurgical, Inc.·20210423
Z-0098-2019 — Colpo-Pneumo Occluder, Part CPO-6Class II·Terminated·CooperSurgical, Inc.·20180904

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K954311.

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