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)

TECHNOMED PULSOLITH LASER SYSTEM

K-Number: K895178 · 1989-10-06

ApplicantTeknomed, Inc.
Decision Date1989-10-06
Product CodeFFK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

TECHNOMED PULSOLITH LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Teknomed, Inc.. It received FDA 510(k) clearance on 1989-10-06 under 510(k) number K895178. The device is classified under product code FFK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TECHNOMED PULSOLITH LASER SYSTEM?

TECHNOMED PULSOLITH LASER SYSTEM is a medical device that received FDA 510(k) clearance on 1989-10-06. The listed applicant is Teknomed, Inc.. The 510(k) number is K895178.

When did TECHNOMED PULSOLITH LASER SYSTEM receive FDA 510(k) clearance?

TECHNOMED PULSOLITH LASER SYSTEM received FDA 510(k) clearance on 1989-10-06, under 510(k) number K895178.

Who is the listed applicant for TECHNOMED PULSOLITH LASER SYSTEM?

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

What is the FDA product code for TECHNOMED PULSOLITH LASER SYSTEM?

The FDA product code for TECHNOMED PULSOLITH LASER SYSTEM is FFK.

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 Teknomed, 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.

K925395TECHNOMED PULSOLITH 4000 LASER SYSTEMK920708MULTILASE 2500 AK913917MULTILASE 2100 C, 2100 DK913290MULTILASE 2100 AK890436TECHNOMED PULSOLITH LASER SYSTEMK790132TECNOTOMO

View all 7 devices →

Related Devices (Code: FFK)

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.

K242888Electrohydraulic Lithotriptor (TCS-B3-II)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.K243032EHL Probe (SCDG-AS); EHL Probe (SCDG-BS); EHL Probe (SCDG-CS)Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.K230488EL27-Compact; Sterile EHL-ProbesWalz Elektronik GmbHK202813URO-TOUCH 9 French ProbeNorthgate Technologies, Inc.K191124Swiss LithoClast TrilogyE.M.S Electro Medical Systems S.AK162119UreTron PF Series ProbeMed-Sonics Corp.

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.

↑