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510(k) K162415

Spectra 9Plus by Uzinmedicare Company — Product Code HGX

K162415 is an FDA 510(k) premarket notification submitted by Uzinmedicare Company for the device "Spectra 9Plus". The FDA issued a decision of Substantially Equivalent on Mar 15, 2017. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160. Uzinmedicare Company has 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Mar 15, 2017
Date Received
Aug 29, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Breast, Powered
Device Class
Class II
Regulation Number
884.5160
Review Panel
OB
Submission Type
510(k)

Other clearances by Uzinmedicare Company

  • K210124 — Synergy Gold (SG) Portable (Models MM011450 and MM011460) (Oct 19, 2021)
  • K191109 — Spectra Q (Jan 22, 2020)
  • K191208 — Spectra Cashmere (Oct 11, 2019)
  • K181784 — Spectra S3 Plus (Nov 30, 2018)
  • K150476 — Spectra S1Plus and Spectra S2 Plus (Apr 15, 2016)
  • K093145 — SPECTRA SERIES BREAST PUMP (Aug 13, 2010)

Other clearances for product code HGX

  • K254203 — Wearable Breast Pump (Model S36) (Sep 17, 2026)
  • K261622 — Philips Avent Natural Care Hands-free Wearable Electric Breast Pump (Model… (Sep 3, 2026)
  • K262774 — Wearable breast pump (Model: XN/MD-2249BS, ZFHF) (Sep 1, 2026)
  • K260643 — Cimilre Dual Max (Aug 21, 2026)
  • K261298 — Wearable Electric Breast Pump (YM-8837, YM-8838, YM-8856(H03), YM-8809(S42)) (Aug 20, 2026)
  • K260259 — DiscreetDuo™ Flow Wearable Breast Pump (Model S3) (Jul 24, 2026)
  • K261199 — Wearable Breast Pump (Model S32A) (Jul 13, 2026)
  • K250070 — Electric breast pump (MY-375,MY-376,MY-378,MY-379,MY-380,V3) (Jun 26, 2026)
  • K261025 — Wearable breast pump (QY-101, QY-102, QY-108) (Jun 25, 2026)
  • K254254 — Momcozy Wearable Breast Pump (BP311, BP311-A, BP311-B, BP311-C, BP311-D) (Jun 18, 2026)

FDA data resources