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FDA 510(k)

SMOKE/ODOR EVACUATOR #757

K-Number: K912612 · 1991-11-01

ApplicantOlsen Electrosurgical, Inc.
Decision Date1991-11-01
Product CodeFYD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SMOKE/ODOR EVACUATOR #757 is the device name listed in this FDA 510(k) record. The listed applicant is Olsen Electrosurgical, Inc.. It received FDA 510(k) clearance on 1991-11-01 under 510(k) number K912612. 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/ODOR EVACUATOR #757?

SMOKE/ODOR EVACUATOR #757 is a medical device that received FDA 510(k) clearance on 1991-11-01. The listed applicant is Olsen Electrosurgical, Inc.. The 510(k) number is K912612.

When did SMOKE/ODOR EVACUATOR #757 receive FDA 510(k) clearance?

SMOKE/ODOR EVACUATOR #757 received FDA 510(k) clearance on 1991-11-01, under 510(k) number K912612.

Who is the listed applicant for SMOKE/ODOR EVACUATOR #757?

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

What is the FDA product code for SMOKE/ODOR EVACUATOR #757?

The FDA product code for SMOKE/ODOR EVACUATOR #757 is FYD.

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Other records listing Olsen Electrosurgical, 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.

K922154INSULATED SPECULUM W/ SMOKE EVACUATOR OPTIONK912611OLSEN LAPAROSCOPIC INSTR, DISPOSABLE, SINGLE USEK913108TEFLON COATED ELECTRODES/ELECTRODES HANDLESK885200600 & 900 SERIES ELECTRODES & 755 & 756 HANDLEK885199#500 SERIES FORCEPS W/CUT/COAGULATE SWITCHESK884171#875 DISPOSABLE BIOPOLAR CABLE

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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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