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510(k) K011519

AMEDA HYGIENIKIT by Hollister, Inc. — Product Code HGY

K011519 is an FDA 510(k) premarket notification submitted by Hollister, Inc. for the device "AMEDA HYGIENIKIT". The FDA issued a decision of Substantially Equivalent on Aug 15, 2001. The device falls under product code HGY (Pump, Breast, Non-Powered), a Class I device regulated under 21 CFR 884.5150. Hollister, Inc. has 84 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Aug 15, 2001
Date Received
May 17, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Pump, Breast, Non-Powered
Device Class
Class I
Regulation Number
884.5150
Review Panel
OB
Submission Type
510(k) Exempt

Other clearances by Hollister, Inc.

  • K123804 — INSTAFLO BOWEL CATHETER SYSTEM KIT (Apr 17, 2013)
  • K100273 — INSTAFLO BOWEL CATHETER SYSTEM KIT (Apr 22, 2010)
  • K090960 — VAPRO INTERMITTENT CATHETER, MODEL 72062, 72082,72102, 72122, 72142, 72064… (Aug 20, 2009)
  • K083153 — ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007 (Feb 4, 2009)
  • K050483 — EVADRI BLADDER CONTROL SYSTEMS (Apr 12, 2005)
  • K040779 — RESTORE WOUND CLEANSER (May 17, 2004)
  • K013612 — INCARE PELVIC FLOOR THERAPY SYSTEM (Mar 19, 2002)
  • K013653 — INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBE (Mar 5, 2002)
  • K013483 — INCARE ADVANCE; INTERMITTENT CATHETER, PLUS INTERMITTENT CATHETER, PLUS KIT (Jan 14, 2002)
  • K013345 — INCARE INTERMITTENT CATHETER (Jan 7, 2002)

Other clearances for product code HGY

  • K101538 — HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP) (Nov 5, 2010)
  • K032845 — EASY COMFORT DELUXE MANUAL BREAST PUMP, MODEL 1187 (Apr 5, 2004)
  • K013226 — EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT (Dec 20, 2001)
  • K971231 — WHITE RIVER MINI MANUAL BREAST PUMP (May 19, 1997)
  • K962828 — EVERT-IT (Feb 10, 1997)
  • K952034 — MEDELA'S FOOT PUMP (Sep 12, 1995)
  • K952035 — NIPLETTE (Jul 28, 1995)
  • K925738 — WHITE RIVER MANUAL BREAST PUMP (May 4, 1994)
  • K912355 — MOTHERS TOUCH ONE HAND BREAST PUMP (Dec 10, 1993)
  • K902552 — GERBER PRECIOUS CARE ELECTRIC BREAST PUMP (Sep 26, 1990)

FDA data resources

Source: FDA 510(k) database entry for K011519. Report a data issue: hello@regdatalab.com.