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FDA 510(k)

SMOKE EVACUATION ATTACHEMENT

K-Number: K033095 · 2004-11-17

ApplicantModern Medical Equipment Mfg., Ltd.
Decision Date2004-11-17
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SMOKE EVACUATION ATTACHEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Modern Medical Equipment Mfg., Ltd.. It received FDA 510(k) clearance on 2004-11-17 under 510(k) number K033095. 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 EVACUATION ATTACHEMENT?

SMOKE EVACUATION ATTACHEMENT is a medical device that received FDA 510(k) clearance on 2004-11-17. The listed applicant is Modern Medical Equipment Mfg., Ltd.. The 510(k) number is K033095.

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

SMOKE EVACUATION ATTACHEMENT received FDA 510(k) clearance on 2004-11-17, under 510(k) number K033095.

Who is the listed applicant for SMOKE EVACUATION ATTACHEMENT?

The FDA 510(k) record lists Modern Medical Equipment Mfg., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMOKE EVACUATION ATTACHEMENT?

The FDA product code for SMOKE EVACUATION ATTACHEMENT is GEI.

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Other records listing Modern Medical Equipment Mfg., Ltd. 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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