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FDA 510(k)

SMOKE-EVAC

K-Number: K981888 · 1998-10-15

ApplicantBio-Medical Devices, Inc.
Decision Date1998-10-15
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SMOKE-EVAC is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Medical Devices, Inc.. It received FDA 510(k) clearance on 1998-10-15 under 510(k) number K981888. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMOKE-EVAC?

SMOKE-EVAC is a medical device that received FDA 510(k) clearance on 1998-10-15. The listed applicant is Bio-Medical Devices, Inc.. The 510(k) number is K981888.

When did SMOKE-EVAC receive FDA 510(k) clearance?

SMOKE-EVAC received FDA 510(k) clearance on 1998-10-15, under 510(k) number K981888.

Who is the listed applicant for SMOKE-EVAC?

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

What is the FDA product code for SMOKE-EVAC?

The FDA product code for SMOKE-EVAC is GEI.

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Other records listing Bio-Medical Devices, Inc. as applicant

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Related Devices (Code: GEI)

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.

K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)Stryker InstrumentsK254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLCK261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLCK254185Potenza PrimeJeisys Medical IncorporatedK262364Ellian Enigma RF DeviceEllian CorpK253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.

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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