AMEDA HYGIENIKIT— 510(k) K011519

Substantially Equivalent

Hollister, Inc.

FDA 510(k) clearance K011519 for AMEDA HYGIENIKIT, Substantially Equivalent on 2001-08-15. Applicant: Hollister, Inc.. Device class: 1.

Clearance details

Applicant: Hollister, Inc.
Product code: Code HGY
Device class: Class 1
Regulation: 21 CFR 884.5150
Advisory panel: Obstetrics/Gynecology
Date received: 2001-05-17
Decision date: 2001-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Libertyville, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HGY

K101538 — HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP)2010-11-05
K032845 — EASY COMFORT DELUXE MANUAL BREAST PUMP, MODEL 11872004-04-05
K013226 — EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT2001-12-20
K971231 — WHITE RIVER MINI MANUAL BREAST PUMP1997-05-19
K962828 — EVERT-IT1997-02-10

More clearances from Hollister, Inc.

Recalls naming K011519

K-number listed on FDA's recall record

Z-1327-2015 — Ameda Dual Short Term HygieniKit Milk Collections System (SKU 17115) - Primary packaging is 12 pouches with Tyvek header (10.75 x 16.375 x 3") within a secondary corrugated shipper (20.75 x 15.50 x 8.5" inner dimensions). The device is intended to be connected to a powered breast pump or adapted for use with a manual breast pump to express and collect the mother's milk of a nursing woman for the purpose of feeding the collected milk to a baby.Class II·Terminated·Ameda, Inc.·20150212

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K011519.

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