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)

BURKE BARIATRIC TREATMENT SYSTEM II

K-Number: K925576 · 1993-06-04

ApplicantBurke Mobility Products
Decision Date1993-06-04
Product CodeFNL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BURKE BARIATRIC TREATMENT SYSTEM II is the device name listed in this FDA 510(k) record. The listed applicant is Burke Mobility Products. It received FDA 510(k) clearance on 1993-06-04 under 510(k) number K925576. The device is classified under product code FNL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BURKE BARIATRIC TREATMENT SYSTEM II?

BURKE BARIATRIC TREATMENT SYSTEM II is a medical device that received FDA 510(k) clearance on 1993-06-04. The listed applicant is Burke Mobility Products. The 510(k) number is K925576.

When did BURKE BARIATRIC TREATMENT SYSTEM II receive FDA 510(k) clearance?

BURKE BARIATRIC TREATMENT SYSTEM II received FDA 510(k) clearance on 1993-06-04, under 510(k) number K925576.

Who is the listed applicant for BURKE BARIATRIC TREATMENT SYSTEM II?

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

What is the FDA product code for BURKE BARIATRIC TREATMENT SYSTEM II?

The FDA product code for BURKE BARIATRIC TREATMENT SYSTEM II is FNL.

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 Burke Mobility Products 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.

K954974PACE SAVER LITTLE JUNIOR (MODIFICATION)K925122PACE SAVER LITTLE JRK900738BOOSTER MOTORIZED THREE WHEELED VEHICLE

Related Devices (Code: FNL)

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.

K202964iBed Wireless with iBed MobileStryker CorporationK103536IBED WIRELESS WITH IBED AWARENESSStryker CorporationK982783VAIL 1000 ENCLOSED BEDVail Products, Inc.K974296MODEL 720 SERIES FULL/SEMI ELECTRIC BED 1120 FULL ELECTRIC BEDInvacare Corp.K974254BENEFIT B3--- SERIESM.C. Healthcare Products, Inc.K972115VOLKER HOSPITAL BED, MODEL K960Volker Healthcare, Inc.

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.

↑