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)

5.0 MM IRRIGATION/ASPIRATION PROBE

K-Number: K931856 · 1993-08-10

Decision Date1993-08-10
Product CodeGCY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

5.0 MM IRRIGATION/ASPIRATION PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Mayaguez Medical Center. It received FDA 510(k) clearance on 1993-08-10 under 510(k) number K931856. The device is classified under product code GCY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 5.0 MM IRRIGATION/ASPIRATION PROBE?

5.0 MM IRRIGATION/ASPIRATION PROBE is a medical device that received FDA 510(k) clearance on 1993-08-10. The listed applicant is Mayaguez Medical Center. The 510(k) number is K931856.

When did 5.0 MM IRRIGATION/ASPIRATION PROBE receive FDA 510(k) clearance?

5.0 MM IRRIGATION/ASPIRATION PROBE received FDA 510(k) clearance on 1993-08-10, under 510(k) number K931856.

Who is the listed applicant for 5.0 MM IRRIGATION/ASPIRATION PROBE?

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

What is the FDA product code for 5.0 MM IRRIGATION/ASPIRATION PROBE?

The FDA product code for 5.0 MM IRRIGATION/ASPIRATION PROBE is GCY.

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.

Other records listing Mayaguez Medical Center 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.

View all 10 devices →

Related Devices (Code: GCY)

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.

↑