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510(k) K101538

HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP) by Philips Electronics UK Limited — Product Code HGY

K101538 is an FDA 510(k) premarket notification submitted by Philips Electronics UK Limited for the device "HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP)". The FDA issued a decision of Substantially Equivalent on November 5, 2010. The device falls under product code HGY (Pump, Breast, Non-Powered), a Class I device regulated under 21 CFR 884.5150. Philips Electronics UK Limited has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 2010
Date Received
June 3, 2010
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

Other clearances by Philips Electronics UK Limited

  • K100495 — PHILIPS AVENT DIGITAL THERMOMETER SET, MODEL SCH540 (June 22, 2010)
  • K090167 — PHILIPS AVENT CLASSIC STAGE 2 AND 3 TEETHER, MODEL SCF882/01, SCF884/01, PHILIPS (June 18, 2009)

Other clearances for product code HGY

  • K032845 — EASY COMFORT DELUXE MANUAL BREAST PUMP, MODEL 1187 (April 5, 2004)
  • K013226 — EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT (December 20, 2001)
  • K011519 — AMEDA HYGIENIKIT (August 15, 2001)
  • K971231 — WHITE RIVER MINI MANUAL BREAST PUMP (May 19, 1997)
  • K962828 — EVERT-IT (February 10, 1997)
  • K952034 — MEDELA'S FOOT PUMP (September 12, 1995)
  • K952035 — NIPLETTE (July 28, 1995)
  • K925738 — WHITE RIVER MANUAL BREAST PUMP (May 4, 1994)
  • K912355 — MOTHERS TOUCH ONE HAND BREAST PUMP (December 10, 1993)
  • K902552 — GERBER PRECIOUS CARE ELECTRIC BREAST PUMP (September 26, 1990)

FDA data resources