Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

GENERA 100 SURGICAL SYSTEM

K-Number: K945181 · 1995-01-20

ApplicantXintec Corporation
Decision Date1995-01-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GENERA 100 SURGICAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Xintec Corporation. It received FDA 510(k) clearance on 1995-01-20 under 510(k) number K945181. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GENERA 100 SURGICAL SYSTEM?

GENERA 100 SURGICAL SYSTEM is a medical device that received FDA 510(k) clearance on 1995-01-20. The listed applicant is Xintec Corporation. The 510(k) number is K945181.

When did GENERA 100 SURGICAL SYSTEM receive FDA 510(k) clearance?

GENERA 100 SURGICAL SYSTEM received FDA 510(k) clearance on 1995-01-20, under 510(k) number K945181.

Who is the listed applicant for GENERA 100 SURGICAL SYSTEM?

The FDA 510(k) record lists Xintec Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GENERA 100 SURGICAL SYSTEM?

The FDA product code for GENERA 100 SURGICAL SYSTEM is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Xintec Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K082230VECTRA PLUS LASER SYSTEM AND ACCESSORIESK990914POLARIS DIODE LASER SYSTEM AND ACCESSORIESK981627PROTEGE II ER: YAG LASER SYSTEM AND ACCESSOIES (UPGRADE)K981350ALEXIS ALEXANDRITE LASER SYSTEM AND ACCESSORIESK971912PROTEGE ER:YAG LASER SYSTEM AND ACCESSORIESK971065DENTICA PULSED ND: YAG LASER SYSTEMS AND ACCESSORIES

View all 26 devices →

Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.K252723Dynamis Pro FamilyFotona D.O.O.K241973SmartIPL_NI SystemLumenis Be, Ltd.K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑