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FDA 510(k)

ELASTIC BANDAGE

K-Number: K843056 · 1984-12-04

ApplicantSterile Medical Systems
Decision Date1984-12-04
Product CodeGAX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ELASTIC BANDAGE is the device name listed in this FDA 510(k) record. The listed applicant is Sterile Medical Systems. It received FDA 510(k) clearance on 1984-12-04 under 510(k) number K843056. The device is classified under product code GAX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELASTIC BANDAGE?

ELASTIC BANDAGE is a medical device that received FDA 510(k) clearance on 1984-12-04. The listed applicant is Sterile Medical Systems. The 510(k) number is K843056.

When did ELASTIC BANDAGE receive FDA 510(k) clearance?

ELASTIC BANDAGE received FDA 510(k) clearance on 1984-12-04, under 510(k) number K843056.

Who is the listed applicant for ELASTIC BANDAGE?

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

What is the FDA product code for ELASTIC BANDAGE?

The FDA product code for ELASTIC BANDAGE is GAX.

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Related Devices (Code: GAX)

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.

K931198UNIQUETIcat SystemsK881398TOURNIQUETBarretta Products, Research and Development, Inc.K881176STERILE ESMARCH BANDAGESpectrum/Hydro-Med Products, Inc.K875092DEGANIA SILICONE TOURNIQUETDegania Silicone , Ltd.K873928UNIVERSAL TOURNIQUETDryden Corp.K872003KINDERWRAPThe Kinder Co.

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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