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510(k) K173070

HSW Resection Instruments by Henke-Sass, Wolf GmbH — Product Code HIH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 2018
Date Received
September 29, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hysteroscope (And Accessories)
Device Class
Class II
Regulation Number
884.1690
Review Panel
OB
Submission Type

Other clearances by Henke-Sass, Wolf GmbH

  • K171336 — Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL (December 7, 2017)
  • K101547 — HENKE- SASS, WOLF PISTON SYRINGE (NORM-JET) (November 22, 2010)
  • K952186 — HSW GMBH HYSTEROSCOPES & ACCESSORIES (February 6, 1996)
  • K943624 — ELMED PNEUMOPERITONEUM NEEDLES (August 10, 1994)
  • K941967 — HSW LAPAROSCOPE AND ACCESSORIES (May 16, 1994)

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