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FDA 510(k)

MODEL III HANDSWITCH

K-Number: K792600 · 1980-01-10

ApplicantSara Dan, Inc.
Decision Date1980-01-10
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODEL III HANDSWITCH is the device name listed in this FDA 510(k) record. The listed applicant is Sara Dan, Inc.. It received FDA 510(k) clearance on 1980-01-10 under 510(k) number K792600. 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 MODEL III HANDSWITCH?

MODEL III HANDSWITCH is a medical device that received FDA 510(k) clearance on 1980-01-10. The listed applicant is Sara Dan, Inc.. The 510(k) number is K792600.

When did MODEL III HANDSWITCH receive FDA 510(k) clearance?

MODEL III HANDSWITCH received FDA 510(k) clearance on 1980-01-10, under 510(k) number K792600.

Who is the listed applicant for MODEL III HANDSWITCH?

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

What is the FDA product code for MODEL III HANDSWITCH?

The FDA product code for MODEL III HANDSWITCH is GEI.

Related Clinical Trials

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.

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Other records listing Sara Dan, 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.

K790684COLOR CODING OF SURGICAL INSTRUMENTS

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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