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510(k) K091958

BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM by Glenveigh Surgical, LLC — Product Code OQY

K091958 is an FDA 510(k) premarket notification submitted by Glenveigh Surgical, LLC for the device "BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM". The FDA issued a decision of Substantially Equivalent on April 30, 2010. The device falls under product code OQY (Intrauterine Tamponade Balloon), a Class II device regulated under 21 CFR 884.4530. Glenveigh Surgical, LLC has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 2010
Date Received
July 1, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Intrauterine Tamponade Balloon
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

provides temporary control or reduction of postpartum uterine bleeding

Other clearances by Glenveigh Surgical, LLC

  • K093904 — GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER (April 14, 2010)

Other clearances for product code OQY

  • K253642 — Jada System (Jada-2002) (May 15, 2026)
  • K230849 — ELLAVI UBT (November 13, 2023)
  • K223098 — Bakri Essential Postpartum Balloon (October 28, 2022)
  • K212757 — Jada System (September 30, 2021)
  • K201199 — Jada System (August 28, 2020)
  • K191264 — Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”) (October 30, 2019)
  • K170622 — Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Compo (March 31, 2017)
  • K153591 — ebb Complete Tamponade System (January 14, 2016)
  • K150573 — ebb Complete Tamponade System (March 25, 2015)
  • K101535 — BT-CATH (January 11, 2011)

FDA data resources