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510(k) K914153

OTT INSUFFLATOR FILTER PLUS/TUBING SET by Marlo Surgical Technology — Product Code HIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 1992
Date Received
September 16, 1991
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

Other clearances by Marlo Surgical Technology

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  • K962273 — MALLEABLE STYLET 18 CM ME1816ST, 23 CM ME1816NST (July 31, 1996)
  • K924611 — IRRIGATION PUMP AND TUBING SET (June 30, 1994)
  • K932832 — PRIMUS INSULATED FORCEPS (February 25, 1994)
  • K932634 — NU-TIP(TM) FORCEPS:GRASPERS/DISSECTORS/SUTURES (February 25, 1994)
  • K920611 — MARLOW LAPAROSCOPIC GRASPING FORCEP (April 20, 1993)
  • K914869 — MARLOW LAPAROSCOPIC SCISSORS (January 15, 1992)
  • K913954 — MARLOW/REDDICK LAPAROSCOPIC NEEDLE HOLDERS (December 18, 1991)
  • K914872 — MARLOW SUCTION/IRRIGATION PROBES (November 19, 1991)
  • K913964 — MARLOW/REDDICK LAPAROSCOPIC GRASPING FORCEPS (October 23, 1991)

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  • K242536 — TauTona Pneumoperitoneum Assist Device (TPAD) (October 15, 2024)
  • K232464 — VereSee Optical Veres Needle System (May 2, 2024)
  • K232902 — EVA15 insufflator (May 2, 2024)
  • K233020 — TauTona Pneumoperitoneum Assist Device (TPAD) (January 12, 2024)
  • K232401 — Disposable Veress Needles (December 14, 2023)
  • K231342 — Insufflator (OPTO-IFL1000) (September 20, 2023)
  • K230239 — AirSeal iFS System; AirSeal dV Solution (September 20, 2023)