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FDA 510(k)

CRYSTAL VISION #250D SMOKE EVACUATOR SYSTEM WITH ACCESSORIES

K-Number: K003840 · 2001-02-01

ApplicantI.C Medical, Inc.
Decision Date2001-02-01
Product CodeFYD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CRYSTAL VISION #250D SMOKE EVACUATOR SYSTEM WITH ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is I.C Medical, Inc.. It received FDA 510(k) clearance on 2001-02-01 under 510(k) number K003840. 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 CRYSTAL VISION #250D SMOKE EVACUATOR SYSTEM WITH ACCESSORIES?

CRYSTAL VISION #250D SMOKE EVACUATOR SYSTEM WITH ACCESSORIES is a medical device that received FDA 510(k) clearance on 2001-02-01. The listed applicant is I.C Medical, Inc.. The 510(k) number is K003840.

When did CRYSTAL VISION #250D SMOKE EVACUATOR SYSTEM WITH ACCESSORIES receive FDA 510(k) clearance?

CRYSTAL VISION #250D SMOKE EVACUATOR SYSTEM WITH ACCESSORIES received FDA 510(k) clearance on 2001-02-01, under 510(k) number K003840.

Who is the listed applicant for CRYSTAL VISION #250D SMOKE EVACUATOR SYSTEM WITH ACCESSORIES?

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

What is the FDA product code for CRYSTAL VISION #250D SMOKE EVACUATOR SYSTEM WITH ACCESSORIES?

The FDA product code for CRYSTAL VISION #250D SMOKE EVACUATOR SYSTEM WITH ACCESSORIES is FYD.

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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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