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FDA 510(k)

SMOKE EATER

K-Number: K923799 · 1993-01-29

ApplicantNordex Medical Corp.
Decision Date1993-01-29
Product CodeFYD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SMOKE EATER is the device name listed in this FDA 510(k) record. The listed applicant is Nordex Medical Corp.. It received FDA 510(k) clearance on 1993-01-29 under 510(k) number K923799. The device is classified under product code FYD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMOKE EATER?

SMOKE EATER is a medical device that received FDA 510(k) clearance on 1993-01-29. The listed applicant is Nordex Medical Corp.. The 510(k) number is K923799.

When did SMOKE EATER receive FDA 510(k) clearance?

SMOKE EATER received FDA 510(k) clearance on 1993-01-29, under 510(k) number K923799.

Who is the listed applicant for SMOKE EATER?

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

What is the FDA product code for SMOKE EATER?

The FDA product code for SMOKE EATER is FYD.

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 Nordex Medical 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.

K930132LEEP AND LLETZ ELECTRODES

Related Devices (Code: FYD)

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.

K240127PlumeSafe X5 Smoke Management SystemConmed CorporationK2337898Q10 Surclear Smoke Plume Evacuation SystemSurnic CorporationK213068Medline Smoke Evacuation ShroudMedline Industries, Inc.K202944NEBULAE SRS Laparoscopic Surgical Smoke Removal SystemNorthgate Technologies, Inc.K200250Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF SensorMegadyne Medical Products, Inc.K192035EvaQMax Smoke Evacuation SystemBio Protech, 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.

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