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510(k) K943624

ELMED PNEUMOPERITONEUM NEEDLES by Henke-Sass, Wolf GmbH — Product Code FHO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 1994
Date Received
July 26, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pneumoperitoneum Needle
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

For establishment of a pneumoperitoneum in abdomen.

Other clearances by Henke-Sass, Wolf GmbH

  • K173070 — HSW Resection Instruments (June 8, 2018)
  • 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)
  • K941967 — HSW LAPAROSCOPE AND ACCESSORIES (May 16, 1994)

Other clearances for product code FHO

  • K172120 — Veress Needle (September 14, 2017)
  • K121370 — VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLE (August 2, 2013)
  • K010779 — MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENT (April 10, 2001)
  • K970788 — PNEUMO-MATIC INSUFFLATION NEEDLE (March 27, 1997)
  • K960574 — ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC C (August 5, 1996)
  • K951894 — ACCESS EXPANSION SYSTEM (June 15, 1995)
  • K942484 — VERRES NEEDLE (June 24, 1994)
  • K930474 — NEEDLE, PNEUMOPERITONEUM, SPRING LOADED (July 23, 1993)
  • K915725 — CLARUS MODELS 1230 AND 1231 LAPARO-NEEDLE (November 16, 1992)
  • K914426 — ENTREE NEEDLE (November 27, 1991)