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FDA 510(k)

XANAR MODEL XSE-300 SMOKE EVACULATER

K-Number: K844087 · 1985-02-27

ApplicantXanar, Inc.
Decision Date1985-02-27
Product CodeFYD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

XANAR MODEL XSE-300 SMOKE EVACULATER is the device name listed in this FDA 510(k) record. The listed applicant is Xanar, Inc.. It received FDA 510(k) clearance on 1985-02-27 under 510(k) number K844087. 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 XANAR MODEL XSE-300 SMOKE EVACULATER?

XANAR MODEL XSE-300 SMOKE EVACULATER is a medical device that received FDA 510(k) clearance on 1985-02-27. The listed applicant is Xanar, Inc.. The 510(k) number is K844087.

When did XANAR MODEL XSE-300 SMOKE EVACULATER receive FDA 510(k) clearance?

XANAR MODEL XSE-300 SMOKE EVACULATER received FDA 510(k) clearance on 1985-02-27, under 510(k) number K844087.

Who is the listed applicant for XANAR MODEL XSE-300 SMOKE EVACULATER?

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

What is the FDA product code for XANAR MODEL XSE-300 SMOKE EVACULATER?

The FDA product code for XANAR MODEL XSE-300 SMOKE EVACULATER is FYD.

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Other records listing Xanar, 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.

K861688XANAR CO2 SURGICAL LASER SYSTEM MODEL XAP-15K852436AMBULASEK860496MODEL NY-110 FOR UPPER & LOWER (GU) & PULMONARYK853620MODEL XA-50 - CO2 SURGICAL LASERK850818CO 2 SURGICAL LASER SYSTEM NA-120K850805CO 2 SURGICAL LASER SYSTEM MODEL NA-40

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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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