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Data / Medical devices / Insufflator, Hysteroscopic / United States

FDA-registered makers of Insufflator, Hysteroscopic in the United States: 18 establishments

18 establishments in the United States are registered with the FDA to make Insufflator, Hysteroscopic (product code HIG). 10 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 2, 2026.

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Device
Insufflator, Hysteroscopic
Product code
HIG
Country
United States

Makers of Insufflator, Hysteroscopic in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Karl Storz Endoscopy-America, Inc.Auburn, MA, United StatesContract manufacturer, Repackager or relabeler5November 30, 2000010api.fda.gov
Gyrus ACMI, Inc.Brooklyn Park, MN, United StatesComplaint file establishment, Repackager or relabeler, Specification developer3January 8, 2002000api.fda.gov
Stryker EndoscopySan Jose, CA, United StatesComplaint file establishment, Specification developer3November 4, 2021010api.fda.gov
Thermedx, LLCSolon, OH, United StatesComplaint file establishment, Manufacturer3September 5, 2017010api.fda.gov
CovidienNorth Haven, CT, United StatesRepackager or relabeler, Specification developer2March 28, 2018000api.fda.gov
Hologic, Inc.Marlborough, MA, United StatesComplaint file establishment, Specification developer2July 25, 2024000api.fda.gov
Hologic, Inc.Marlborough, MA, United StatesManufacturer2July 25, 2024000api.fda.gov
Boston Scientific CorporationMarlborough, MA, United StatesSpecification developer1March 27, 2026000api.fda.gov
Coopersurgical, Inc.Trumbull, CT, United StatesManufacturer1December 19, 1989000api.fda.gov
STRYKER Communications, Inc.Flower Mound, TX, United StatesManufacturer1November 4, 2021000api.fda.gov
Apical InstrumentsRedwood City, CA, United StatesContract manufacturer0000api.fda.gov
Axora Medical, Inc.Sunnyvale, CA, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Command Medical Products, LLC.Ormond Beach, FL, United StatesContract manufacturer0000api.fda.gov
Karl Storz Endovision, Inc.Charlton, MA, United StatesContract manufacturer0000api.fda.gov
Meditrina, Inc.San Jose, CA, United StatesManufacturer, Specification developer0000api.fda.gov
Minerva Surgical, Inc.Santa Clara, CA, United StatesManufacturer0000api.fda.gov
Premier Dental Products Co.Plymouth Meeting, PA, United StatesSpecification developer0000api.fda.gov
Premier MedicalPhiladelphia, PA, United StatesContract manufacturer0000api.fda.gov

Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.