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FDA 510(k)

REFLEX ESP WITH FINGER SWITCHES

K-Number: K935105 · 1994-02-22

ApplicantRichard-Allan Medical
Decision Date1994-02-22
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

REFLEX ESP WITH FINGER SWITCHES is the device name listed in this FDA 510(k) record. The listed applicant is Richard-Allan Medical. It received FDA 510(k) clearance on 1994-02-22 under 510(k) number K935105. 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 REFLEX ESP WITH FINGER SWITCHES?

REFLEX ESP WITH FINGER SWITCHES is a medical device that received FDA 510(k) clearance on 1994-02-22. The listed applicant is Richard-Allan Medical. The 510(k) number is K935105.

When did REFLEX ESP WITH FINGER SWITCHES receive FDA 510(k) clearance?

REFLEX ESP WITH FINGER SWITCHES received FDA 510(k) clearance on 1994-02-22, under 510(k) number K935105.

Who is the listed applicant for REFLEX ESP WITH FINGER SWITCHES?

The FDA 510(k) record lists Richard-Allan Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REFLEX ESP WITH FINGER SWITCHES?

The FDA product code for REFLEX ESP WITH FINGER SWITCHES is GEI.

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Other records listing Richard-Allan Medical 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.

K942207REFLEX INS INSUFFLATION NEEDLEK933508REFLEX SDD SURGICAL STAPLERK933901REFLEX(R) EHS (ENDOSCOPIC HERNIA STAPLER)K924881REFLEX(R) ESPK924929REFLEX(R) ECAK905701RICHARD-ALLAN SHEET CLIP

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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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