Home / 510(k) Clearances / K892501

510(k) K892501

WRIGHT MEDICAL FETASAFE by Wright Medical Corp. — Product Code HGM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1989
Date Received
April 5, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Monitoring, Perinatal
Device Class
Class II
Regulation Number
884.2740
Review Panel
OB
Submission Type

Other clearances by Wright Medical Corp.

  • K203228 — DART-FIRE EDGE Cannulated Screw System (May 11, 2021)
  • K203832 — FuseForce™ Flex Dynamic Compression System (May 7, 2021)
  • K162033 — SALVATION External Fixation System (March 6, 2017)
  • K905129 — BAERVELDT GLAUCOMA IMPLANT (February 11, 1991)
  • K901015 — WRIGHT POCKET DOPPLERS VASCULAR & OBSTETRIC (November 5, 1990)

Other clearances for product code HGM

  • K253021 — ANNE Maternal (February 26, 2026)
  • K250777 — Sonicaid Team3 (September 19, 2025)
  • K241882 — Fetal & Maternal Monitor (F15A, F15A Air) (August 27, 2025)
  • K241368 — Sonicaid Team3 (February 3, 2025)
  • K241009 — PeriCALM Patterns 3.0 (January 10, 2025)
  • K233440 — Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) (July 2, 2024)
  • K231964 — Novii+ Wireless Patch System (December 8, 2023)
  • K222327 — Bloomlife MFM-Pro (February 13, 2023)
  • K220732 — Mural Perinatal Surveillance (June 23, 2022)
  • K200975 — Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum (June 24, 2020)