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510(k) K932432

KRONNER REINFORCING STYLETTE by Unimar, Inc. — Product Code LKF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 1994
Date Received
May 20, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Manipulator/Injector, Uterine
Device Class
Class II
Regulation Number
884.4530
Review Panel
OB
Submission Type

Other clearances by Unimar, Inc.

  • K920803 — HSG TRAY (October 19, 1992)
  • K910317 — UNI-SEM(TM) (May 1, 1991)
  • K904473 — KRONNER MANIPUJECTOR (December 14, 1990)
  • K895659 — HUI MINI-FLEX (December 19, 1989)
  • K895403 — ASPIRETTE ENDOCERVICAL ASPIRATOR (November 29, 1989)
  • K894264 — KDF-2.3 (August 15, 1989)
  • K890848 — CERVEX-BRUSH (May 11, 1989)
  • K854415 — ENDOMETRIAL PIPELLE (March 13, 1986)
  • K810291 — STERILE/DISPOSABLE HSG TRAY (March 18, 1981)

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  • K240364 — RELIEEV Uterine Manipulator Injector (CUMI 5.0) (October 16, 2024)
  • K241693 — FemChec Controlled Saline-Air Device (FCD-250) (September 6, 2024)
  • K222798 — Rejoni Intrauterine Catheter (December 16, 2022)
  • K223064 — ALLY II Uterine Positioning System™ (UPS) (October 28, 2022)
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  • K212505 — DUMI ManipulatOR (January 10, 2022)
  • K181770 — Intrauterine Access Balloon Catheter, Selective Salpingography Catheter (March 29, 2019)