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FDA 510(k)

SMARTVAC SMOKE EVACUATION SYSTEM

K-Number: K970352 · 1997-11-04

ApplicantIsomedix Operations, Inc.
Decision Date1997-11-04
Product CodeFYD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SMARTVAC SMOKE EVACUATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Isomedix Operations, Inc.. It received FDA 510(k) clearance on 1997-11-04 under 510(k) number K970352. 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 SMARTVAC SMOKE EVACUATION SYSTEM?

SMARTVAC SMOKE EVACUATION SYSTEM is a medical device that received FDA 510(k) clearance on 1997-11-04. The listed applicant is Isomedix Operations, Inc.. The 510(k) number is K970352.

When did SMARTVAC SMOKE EVACUATION SYSTEM receive FDA 510(k) clearance?

SMARTVAC SMOKE EVACUATION SYSTEM received FDA 510(k) clearance on 1997-11-04, under 510(k) number K970352.

Who is the listed applicant for SMARTVAC SMOKE EVACUATION SYSTEM?

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

What is the FDA product code for SMARTVAC SMOKE EVACUATION SYSTEM?

The FDA product code for SMARTVAC SMOKE EVACUATION SYSTEM is FYD.

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Other records listing Isomedix Operations, 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.

K950047SCHNEIDER GEX(TM) .014/.018 GUIDEWIRE EXCHANGE CATHETER

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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