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)

GAUZE FLUFF

K-Number: K780394 · 1978-04-10

ApplicantThe Torrent Corp.
Decision Date1978-04-10
Product CodeNAB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GAUZE FLUFF is the device name listed in this FDA 510(k) record. The listed applicant is The Torrent Corp.. It received FDA 510(k) clearance on 1978-04-10 under 510(k) number K780394. The device is classified under product code NAB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GAUZE FLUFF?

GAUZE FLUFF is a medical device that received FDA 510(k) clearance on 1978-04-10. The listed applicant is The Torrent Corp.. The 510(k) number is K780394.

When did GAUZE FLUFF receive FDA 510(k) clearance?

GAUZE FLUFF received FDA 510(k) clearance on 1978-04-10, under 510(k) number K780394.

Who is the listed applicant for GAUZE FLUFF?

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

What is the FDA product code for GAUZE FLUFF?

The FDA product code for GAUZE FLUFF is NAB.

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 The Torrent Corp. 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.

K842461TONGUE DEPRESSORK770621STOCKINETTE, SURGICAL

Related Devices (Code: NAB)

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.

K946015IVALON EXTERNAL SPONGEIvalonK940755ISOLYER (4X4, 8PLY)Isolyer Co.K931610OMNISORB II, NONWOVEN SPONGE, STERILE AND NONOmni Mfg., Inc.K925590MULTI-TRAUMA DRESSINGGam Industries, Inc.K926072K-BAND AND K-CREPEParema , Ltd.K915591STERILE GAUZE PADSEagle Medical, 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.

↑