FDA Device Intelligence
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Insufflator, Laparoscopic

FDA product code HIF · Class 2 · Obstetrics/Gynecology

363
Registered devices
7,497
Adverse events
29
Recalls
178
510(k) clearances

Devices with this code

Gimmi — Gimmi GmbHGrey Sterile packaged joystick 50 per box — ORANGE SURGICAL INSTRUMENTS, LLCNA — Richard Wolf GmbHThoraClear Y Connector — ORANGE SURGICAL INSTRUMENTS, LLCLap-port closure device guides 5mm and 10/12 mm — ORANGE SURGICAL INSTRUMENTS, LLCInsuflow Port — LEXION MEDICAL, LLCGimmi — Gimmi GmbHSMITH & NEPHEW 400 — Smith & Nephew, Inc.COMEG MEDICAL — SOPROTHERMOFLATOR — Karl Storz GmbH & Co. KGPneumosure — STRYKER CORPORATIONInsufflator — Guangdong Optomedic Technologies, Inc.COMEG MEDICAL — SOPROWECK — TELEFLEX INCORPORATEDEVA15 — PALLIARE LIMITEDCO2 Hose and Yoke Shuttle Valve System — NORTHGATE TECHNOLOGIES INC.Insufflator — Scivita Medical Technology Co., Ltd.WECK — TELEFLEX INCORPORATEDEVA15 — PALLIARE LIMITEDRichard Wolf — MECTRA LABS, INC.Lapcap2 — LIFE CARE MEDICAL DEVICES LIMITEDTube set for insufflation, single-use — W.O.M. World of Medicine GmbHJoystick for head lamps — ORANGE SURGICAL INSTRUMENTS, LLCAIRSEAL — Conmed Corporation

Recent recalls

DateFirmReason
2026-06-16Olympus Corporation of the AmericasPotential for unexpected instances where the front panel display turns off unexpectedly, and air delivery (insufflation) ceases.
2026-05-14ConMed CorporationPotential for overpressure alerts.
2026-05-14ConMed CorporationPotential for overpressure alerts.
2026-05-14ConMed CorporationPotential for overpressure alerts.
2026-05-14ConMed CorporationPotential for overpressure alerts.
2026-05-14ConMed CorporationPotential for overpressure alerts.
2026-05-14ConMed CorporationPotential for overpressure alerts.
2026-05-14ConMed CorporationPotential for overpressure alerts.
2026-05-14ConMed CorporationPotential for overpressure alerts.
2026-05-14ConMed CorporationPotential for overpressure alerts.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.