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510(k) K955393

NUMO NM-1000 AUTOMATIC CARBON-DIOXIDE FOR ENDOSCOPE by Surgical Innovations Plc — Product Code HIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 1997
Date Received
November 24, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Insufflator, Laparoscopic
Device Class
Class II
Regulation Number
884.1730
Review Panel
OB
Submission Type

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  • K232401 — Disposable Veress Needles (December 14, 2023)
  • K231342 — Insufflator (OPTO-IFL1000) (September 20, 2023)
  • K230239 — AirSeal iFS System; AirSeal dV Solution (September 20, 2023)