Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

CAST SHOE

K-Number: K781363 · 1978-08-14

Decision Date1978-08-14
Product CodeIPG
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

CAST SHOE is the device name listed in this FDA 510(k) record. The listed applicant is Cutler Biomedical. It received FDA 510(k) clearance on 1978-08-14 under 510(k) number K781363. The device is classified under product code IPG. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAST SHOE?

CAST SHOE is a medical device that received FDA 510(k) clearance on 1978-08-14. The listed applicant is Cutler Biomedical. The 510(k) number is K781363.

When did CAST SHOE receive FDA 510(k) clearance?

CAST SHOE received FDA 510(k) clearance on 1978-08-14, under 510(k) number K781363.

Who is the listed applicant for CAST SHOE?

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

What is the FDA product code for CAST SHOE?

The FDA product code for CAST SHOE is IPG.

Related Devices (Code: IPG)

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.

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.

↑