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)

DIALYZER, ULTRADIFFUSER, DISPOSABLE

K-Number: K770858 · 1977-06-14

ApplicantGambro, Inc.
Decision Date1977-06-14
Product CodeFJG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DIALYZER, ULTRADIFFUSER, DISPOSABLE is the device name listed in this FDA 510(k) record. The listed applicant is Gambro, Inc.. It received FDA 510(k) clearance on 1977-06-14 under 510(k) number K770858. The device is classified under product code FJG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIALYZER, ULTRADIFFUSER, DISPOSABLE?

DIALYZER, ULTRADIFFUSER, DISPOSABLE is a medical device that received FDA 510(k) clearance on 1977-06-14. The listed applicant is Gambro, Inc.. The 510(k) number is K770858.

When did DIALYZER, ULTRADIFFUSER, DISPOSABLE receive FDA 510(k) clearance?

DIALYZER, ULTRADIFFUSER, DISPOSABLE received FDA 510(k) clearance on 1977-06-14, under 510(k) number K770858.

Who is the listed applicant for DIALYZER, ULTRADIFFUSER, DISPOSABLE?

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

What is the FDA product code for DIALYZER, ULTRADIFFUSER, DISPOSABLE?

The FDA product code for DIALYZER, ULTRADIFFUSER, DISPOSABLE is FJG.

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 Gambro, 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.

K083158EXALIS, SOFTWARE VERSION 1.15K070643PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35K032431PRISMA M60/M100 SETSK896758GAMBRO BICARBONATE MONITOR BCM 10-3K896757GAMBRO AK-10 DIALYSIS SYSTEM FOR HIGH FLOWSK902481GAMBRO ALWALL GFS PLUS 11, 16 & 20 HOLLOW FIBER

View all 86 devices →

Related Devices (Code: FJG)

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.

K933681GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERSCobe Renal Care, Inc.K933680GAMBRO LUNDIA PRO 200 DIALYZERCobe Renal Care, Inc.K920693DEXTROLYTE II PERITONEAL DIALYSIS 48-3028-9National Medical Care, Medical Products Div., Inc.K915504GAMBRO LUNDIA ALPHA HEMODIALYZERSC.G.H. Medical, Inc.K901368HEMOSPAL KITS A1, A2D, AO, & A1DGambro-Hospal, Inc.K902203TENCKHOFF PERITONEAL DIALYSIS KITAkcess Medical Products, 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.

↑