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Data / Medical devices / Pneumoperitoneum Needle

Pneumoperitoneum Needle (FHO): 17 FDA-registered makers in 5 countries

17 establishments in 5 countries are registered with the FDA to make Pneumoperitoneum Needle (product code FHO, Class 2, 21 CFR 876.1500). 8 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 15 510(k) clearances under this code, the latest on September 14, 2017, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
FHO
Device class
2
Regulation
876.1500
Medical specialty
Gastroenterology, Urology

Makers by country

CountryMakers
United States9
China4
Taiwan2
Turkey1
Mexico1

Makers of Pneumoperitoneum Needle

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Conmed CorporationUtica, NY, United StatesComplaint file establishment, Manufacturer1November 27, 1991000api.fda.gov
Coopersurgical, Inc.Trumbull, CT, United StatesManufacturer1March 27, 1997000api.fda.gov
ConMed CorporationGreenwood Village, CO, United StatesSpecification developer1November 27, 1991000api.fda.gov
CovidienNorth Haven, CT, United StatesContract manufacturer, Manufacturer, Specification developer1October 2, 1986000api.fda.gov
CovidienPonce, PR, United StatesContract manufacturer, Manufacturer1October 2, 1986000api.fda.gov
Medtronic Distribution CenterMemphis, TN, United StatesManufacturer1October 2, 1986000api.fda.gov
Ranfac Corp.Avon, MA, United StatesContract manufacturer, Manufacturer1July 23, 1993000api.fda.gov
Sanmed Medikal Otomotiv Tekstil Ticaret Limited SirketiIstanbul, TurkeyExporter to the US, Manufacturer1October 2, 1986000api.fda.gov
CELESTICA de MONTERREY S.A. de C.V.Apodaca Nuevo Leon, MexicoContract manufacturer0000api.fda.gov
Geotec, Inc.Warwick, RI, United StatesContract manufacturer0000api.fda.gov
Guangzhou T.K Medical Instrument Co., Ltd.Guangzhou Guangdong, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Hangzhou Kangji Medical Instrument Co., Ltd.HANGZHOU Zhejiang, ChinaManufacturer0000api.fda.gov
MEDLINE INDUSTRIES, LP - NorthfieldNorthfield, IL, United StatesSpecification developer0000api.fda.gov
Tianjin Uwell Medical Device Manufacturing Co LtdTianjin, ChinaManufacturer0000api.fda.gov
Unimax Medical Systems Inc.New Taipei City, TaiwanExporter to the US, Specification developer0000api.fda.gov
Unimax Medical Systems Inc.Yilan County, TaiwanManufacturer0000api.fda.gov
Unimicro Medical Systems (shenzhen) Co., Ltd.ShenZhen Guangdong, ChinaManufacturer0000api.fda.gov

Updated September 14, 2017. 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.