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Data / Medical devices / Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

Unit, Electrosurgical, Endoscopic (With Or Without Accessories) (KNS): 72 FDA-registered makers in 13 countries

72 establishments in 13 countries are registered with the FDA to make Unit, Electrosurgical, Endoscopic (With Or Without Accessories) (product code KNS, Class 2, 21 CFR 876.4300). 45 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 189 510(k) clearances under this code, the latest on September 3, 2026, and lists 25 recall events (1 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
KNS
Device class
2
Regulation
876.4300
Medical specialty
Gastroenterology, Urology

Makers by country

CountryMakers
United States28
Germany15
China8
Japan4
Ireland3
United Kingdom3
Costa Rica2
South Korea2
France2
Mexico2
Vietnam1
Czechia1
Thailand1

Makers of Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

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
Olympus Medical Systems Corp.HACHIOJI-SHI Tokyo, JapanSpecification developer14November 25, 2025000api.fda.gov
AOMORI OLYMPUS CO., LTD. Kuroishi SiteKUROISHI-SHI Aomori, JapanManufacturer13November 25, 2025010api.fda.gov
Boston Scientific CorporationMarlborough, MA, United StatesComplaint file establishment, Specification developer12September 3, 2026051api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer, Manufacturer for export11September 3, 2026000api.fda.gov
Boston Scientific LimitedGALWAY Galway(County), IrelandManufacturer11September 3, 2026000api.fda.gov
Boston Scientific CorporationEl Coyol Alajuela, Costa RicaManufacturer7October 27, 2023000api.fda.gov
Wilson-Cook Medical Inc.Winston Salem, NC, United StatesComplaint file establishment, Manufacturer7September 29, 2025060api.fda.gov
Gyrus ACMI, Inc.Brooklyn Park, MN, United StatesComplaint file establishment, Manufacturer, Specification developer6December 14, 2012000api.fda.gov
Olympus Vietnam Co. Ltd.Dong Nai City, VietnamManufacturer5October 17, 2025000api.fda.gov
Creo Medical LtdCHEPSTOW Monmouthshire, United KingdomSpecification developer4June 6, 2025000api.fda.gov
Boston Scientific LimitedCORK Munster, IrelandManufacturer3September 3, 2026000api.fda.gov
Hangzhou AGS MedTech Co., Ltd.Hangzhou Zhejiang, ChinaManufacturer, Repackager or relabeler3May 3, 2023000api.fda.gov
United States Endoscopy Group, Inc.Mentor, OH, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler3September 7, 2010000api.fda.gov
Boston Scientific Corp., Marina Bay Cust. Fulfillment CenterQuincy, MA, United StatesManufacturer, Manufacturer for export2September 3, 2026000api.fda.gov
Boston Scientific CorporationSaint Paul, MN, United StatesComplaint file establishment, Manufacturer, Manufacturer for export2September 3, 2026000api.fda.gov
Conmed CorporationUtica, NY, United StatesComplaint file establishment, Manufacturer2September 10, 1998000api.fda.gov
Cook Ireland LtdLIMERICK Limerick(County), IrelandComplaint file establishment, Manufacturer2April 22, 2005000api.fda.gov
Conmed CorporationWestborough, MA, United StatesSpecification developer2September 10, 1998000api.fda.gov
Covidien llcSanta Clara, CA, United StatesSpecification developer2January 18, 2018000api.fda.gov
Endo-Therapeutics, Inc.Clearwater, FL, United StatesManufacturer2May 8, 1980000api.fda.gov
Olympus Winter & Ibe GMBHHamburg, GermanyComplaint file establishment, Exporter to the US, Manufacturer, Specification developer2March 24, 2003000api.fda.gov
Olympus Medical Products CzechPrerov II Predmosti, CzechiaManufacturer2March 24, 2003000api.fda.gov
Starmed Co.,ltdIlsandong-gu, Goyang-si Gyeonggi, South KoreaManufacturer2October 25, 2023000api.fda.gov
Taewoong Medical Co., LtdGimpo-Si Gyeonggi, South KoreaManufacturer2May 21, 2026000api.fda.gov
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyManufacturer1November 9, 1994000api.fda.gov
Ags Medtech (thailand) Co., Ltd.Pluak Daeng District Rayong, ThailandManufacturer1May 3, 2023000api.fda.gov
Anrei Medical (Hangzhou) Co., Ltd.HANGZHOU Zhejiang, ChinaManufacturer1March 21, 2022000api.fda.gov
Apyx Medical CorporationClearwater, FL, United StatesManufacturer1January 30, 1995000api.fda.gov
Beijing ZKSK Technology Co., Ltd.beijing, ChinaManufacturer1February 6, 2025000api.fda.gov
Boston Scientific CorporationSpencer, IN, United StatesManufacturer1March 20, 1981000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer1August 4, 1988000api.fda.gov
Cook IncorporatedSpencer, IN, United StatesManufacturer1August 4, 1988000api.fda.gov
Francis MedicalMaple Grove, MN, United StatesManufacturer1November 26, 2025000api.fda.gov
Hobbs Medical, Inc.Stafford Springs, CT, United StatesContract manufacturer, Manufacturer1August 2, 2010000api.fda.gov
Horizons Intl. Corp.Heredia, Costa RicaContract manufacturer, Manufacturer, Repackager or relabeler1January 23, 2001000api.fda.gov
Jiangsu Vedkang Medical Science and Technology Co.,Ltd.Changzhou Jiangsu, ChinaManufacturer1March 29, 2024000api.fda.gov
Lamidey Noury MedicalVerrieres Le Buisson Essonne, FranceManufacturer1September 21, 2022000api.fda.gov
Merit Medical Systems, Inc.South Jordan, UT, United StatesManufacturer1September 7, 2010000api.fda.gov
Medfiniti, IncTampa, FL, United StatesManufacturer1January 14, 2003000api.fda.gov
Micro-Tech (Nanjing) Co., Ltd.Nanjing Jiangsu, ChinaManufacturer1December 1, 2021000api.fda.gov
Micro-Tech (Nanjing) Co., Ltd.NAN JING Jiangsu, ChinaManufacturer1December 1, 2021000api.fda.gov
Shirakawa Olympus Co., Ltd.NISHISHIRAKAWA-GUN Fukushima, JapanManufacturer1March 24, 2003000api.fda.gov
Stryker EndoscopySan Jose, CA, United StatesManufacturer, Specification developer1August 9, 2004000api.fda.gov
TeleMed SystemsNorthborough, MA, United StatesSpecification developer1December 22, 1999000api.fda.gov
Zhejiang Soudon Medical Technology Co.,ltdHangzhou Zhejiang, ChinaManufacturer1November 7, 2023000api.fda.gov
Akita Sumitomo Bakelite Co., Ltd.Akita, JapanContract manufacturer, Contract sterilizer0010api.fda.gov
Aptyx - South Glens FallsS Glens Falls, NY, United StatesContract manufacturer0000api.fda.gov
Cme Devices LtdCHEPSTOW Monmouthshire, United KingdomContract manufacturer0000api.fda.gov
Cirtec MedicalEnfield, CT, United StatesContract manufacturer0000api.fda.gov
Consolidated Medical Equipment CompanyChihuahua, MexicoContract manufacturer0000api.fda.gov
Dimeda Instrumente GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Eurofins STERIPAC GMBHCalw-Altburg Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Freudenberg Medical, LLCJeffersonville, IN, United StatesContract manufacturer0000api.fda.gov
Grace Manufacturing IncRussellville, AR, United StatesContract manufacturer0000api.fda.gov
Guenter Bissinger Medizintechnik GMBHTENINGEN Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer0000api.fda.gov
Gyrus Medical Ltd.CARDIFF Wales, United KingdomContract manufacturer0000api.fda.gov
Hebei Lufen Tech Co., LimitedXingtai Hebei, ChinaManufacturer0000api.fda.gov
Karl Storz Se & Co KGTUTTLINGEN Baden-Wurttemberg, GermanySpecification developer0000api.fda.gov
Karl Storz Se & Co. KGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Karl Storz Se & Co. KGTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Karl Storz Se & Co. KGNEUHAUSEN OBECK Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Koscher & Wuertz GMBHSPAICHINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Nortech Systems, Inc.Milaca, MN, United StatesContract manufacturer0000api.fda.gov
Ovesco Endoscopy AGTuebingen Baden-Wurttemberg, GermanyComplaint file establishment, Manufacturer0000api.fda.gov
Olympus Winter & Ibe GmbHTELTOW Brandenburg, GermanyManufacturer0000api.fda.gov
Richard Wolf GMBHKNITTLINGEN Baden-Wurttemberg, GermanyManufacturer0000api.fda.gov
RZ Medizintechnik GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
SEI Medical S.A. de C.V.Juarez Chihuahua, MexicoContract manufacturer0000api.fda.gov
Smith & Nephew Inc.Mansfield, MA, United StatesManufacturer0000api.fda.gov
Statice SABESANCON Doubs, FranceContract manufacturer0000api.fda.gov
Tontarra Medizintechnik GMBHWURMLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Urologix, LLCPlymouth, MN, United StatesManufacturer0000api.fda.gov

Updated September 3, 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.