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FDA 510(k)

STEPPER

K-Number: K771539 · 1977-10-07

ApplicantTridak
Decision Date1977-10-07
Product CodeKYX
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

STEPPER is the device name listed in this FDA 510(k) record. The listed applicant is Tridak. It received FDA 510(k) clearance on 1977-10-07 under 510(k) number K771539. The device is classified under product code KYX. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STEPPER?

STEPPER is a medical device that received FDA 510(k) clearance on 1977-10-07. The listed applicant is Tridak. The 510(k) number is K771539.

When did STEPPER receive FDA 510(k) clearance?

STEPPER received FDA 510(k) clearance on 1977-10-07, under 510(k) number K771539.

Who is the listed applicant for STEPPER?

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

What is the FDA product code for STEPPER?

The FDA product code for STEPPER is KYX.

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Related Devices (Code: KYX)

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.

K980109CYCLOTECH CYCLOSPORINE ORAL SOLUTIONS DISPENSERSangstat Medical Corp.K954181CANYONS BI-DIRECTIONAL CHECK VALVECanyon Medical ProductsK830571BOTTLE ADAPTERBurron Medical Products, Inc.K801008MULTI-AD FLUID DISPENSING PUMP MP-3000Burron Medical Products, Inc.K800362FLUID DISPENSING SYSTEMPharmaseal LaboratoriesK800437SYRINGE TIP CONNECTORBurron Medical Products, Inc.

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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