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)

LASERSONICS ND:YAG CYLINDRICALLY DIFFUSING STERILE DISPOSABLE FIBER

K-Number: K960636 · 1996-08-21

ApplicantHeraeus Surgical, Inc.
Decision Date1996-08-21
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LASERSONICS ND:YAG CYLINDRICALLY DIFFUSING STERILE DISPOSABLE FIBER is the device name listed in this FDA 510(k) record. The listed applicant is Heraeus Surgical, Inc.. It received FDA 510(k) clearance on 1996-08-21 under 510(k) number K960636. 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 LASERSONICS ND:YAG CYLINDRICALLY DIFFUSING STERILE DISPOSABLE FIBER?

LASERSONICS ND:YAG CYLINDRICALLY DIFFUSING STERILE DISPOSABLE FIBER is a medical device that received FDA 510(k) clearance on 1996-08-21. The listed applicant is Heraeus Surgical, Inc.. The 510(k) number is K960636.

When did LASERSONICS ND:YAG CYLINDRICALLY DIFFUSING STERILE DISPOSABLE FIBER receive FDA 510(k) clearance?

LASERSONICS ND:YAG CYLINDRICALLY DIFFUSING STERILE DISPOSABLE FIBER received FDA 510(k) clearance on 1996-08-21, under 510(k) number K960636.

Who is the listed applicant for LASERSONICS ND:YAG CYLINDRICALLY DIFFUSING STERILE DISPOSABLE FIBER?

The FDA 510(k) record lists Heraeus Surgical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LASERSONICS ND:YAG CYLINDRICALLY DIFFUSING STERILE DISPOSABLE FIBER?

The FDA product code for LASERSONICS ND:YAG CYLINDRICALLY DIFFUSING STERILE DISPOSABLE FIBER 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 Heraeus Surgical, Inc. 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.

K955734LASERSONICS PARASCAN DOSIMETER DEVICEK953917LASESONICS LOW POWER CO2 LASER SYSTEMK951215LASERSONICS ULTRALINE III STERILE DISPOSABLE FIBERK943716LASERSONICS SURGICAL LASER SYSTEMS AND ACCESSORIESK944346LASERSONICS RADIANCE DIODE LASER SYSTEMS AND ACCESSORIESK935604LASERSONICS TISSUE MORCELLATOR SET

View all 8 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.

↑