FDA Device Intelligence
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Insufflator, Laparoscopic

FDA product code HIF · Class 2 · Obstetrics/Gynecology

365
Registered devices
7,734
Adverse events
29
Recalls
179
510(k) clearances

Devices with this code

3 Ring Suture Passer - 18 cm Bariatric Kit — ORANGE SURGICAL INSTRUMENTS, LLCPNEUMOCLEAR — W.O.M. World of Medicine GmbHEVA15 — PALLIARE LIMITEDInsufflator 50L — W.O.M. World of Medicine GmbHInsufflator 500 — Smith & Nephew, Inc.NA — Richard Wolf GmbHInsufflator — Guangdong Optomedic Technologies, Inc.SMITH & NEPHEW 400 — Smith & Nephew, Inc.COMEG MEDICAL — SOPRORetrieval Pouch (Multi Deploy) 10/12mm — ORANGE SURGICAL INSTRUMENTS, LLCNA — Richard Wolf GmbHExtension cable for aeration — OLYMPUS MEDICAL SYSTEMS CORP.N/A — Smith & Nephew, Inc.Gimmi — Gimmi GmbHInsuflow Port — LEXION MEDICAL, LLCSTORZ — Canadian Hospital Specialties LimitedNA — Richard Wolf GmbHDiversatek Healthcare — DIVERSATEK HEALTHCARE, INC.COMEG MEDICAL — SOPROInsufflator — Scivita Medical Technology Co., Ltd.NA — Richard Wolf GmbHNA — Richard Wolf GmbHVereSee — Freyja Healthcare, LLCTube set for insufflation, single-use — W.O.M. World of Medicine GmbH

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.