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510(k) K200248

Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators by Allwin Medical Devices, Inc. — Product Code MQF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 2020
Date Received
January 31, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Assisted Reproduction
Device Class
Class II
Regulation Number
884.6110
Review Panel
OB
Submission Type

Other clearances by Allwin Medical Devices, Inc.

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  • K220730 — allFlex Ureteral Catheters, Krait Ureteral Catheters (October 13, 2022)
  • K203626 — SureStrip Vitrification Straw, SureLock Vitrification Straw (June 4, 2021)
  • K190659 — Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via Ureter (December 2, 2019)
  • K190590 — Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double (November 25, 2019)
  • K190522 — Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intr (November 14, 2019)

Other clearances for product code MQF

  • K253354 — Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175 (February 12, 2026)
  • K243373 — Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - (July 23, 2025)
  • K240307 — VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH) (August 16, 2024)
  • K231730 — FemaSeed Intratubal Insemination (September 22, 2023)
  • K220010 — Daylily Single Use Sterile Embryo Transfer Catheter (December 16, 2022)
  • K192540 — Kitazato ET Catheters (May 1, 2020)
  • K190522 — Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intr (November 14, 2019)
  • K191015 — Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Cat (May 17, 2019)
  • K180302 — Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, S (October 24, 2018)
  • K173431 — Towako Transmyometrial Embryo Transfer Set (May 18, 2018)