FDA 510(k)

OXY-BLOC

K-Number: K931044 · 1993-10-04

Decision Date1993-10-04

Product CodeMNK

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

OXY-BLOC is the device name listed in this FDA 510(k) record. The listed applicant is Gi Supply. It received FDA 510(k) clearance on 1993-10-04 under 510(k) number K931044. The device is classified under product code MNK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OXY-BLOC?

OXY-BLOC is a medical device that received FDA 510(k) clearance on 1993-10-04. The listed applicant is Gi Supply. The 510(k) number is K931044.

When did OXY-BLOC receive FDA 510(k) clearance?

OXY-BLOC received FDA 510(k) clearance on 1993-10-04, under 510(k) number K931044.

Who is the listed applicant for OXY-BLOC?

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

What is the FDA product code for OXY-BLOC?

The FDA product code for OXY-BLOC is MNK.

Other records listing Gi Supply 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.

K191923EverLift Submucosal Lifting Agent K031360GI SUPPLY BILIARY STENT K012411HP-ONE K970186GI SUPPLY PARACENTESIS PUMP K970187RUNYON LARGE VOLUME PARACENTESIS KIT K944903HP-FAST

View all 8 devices →

Related Devices (Code: MNK)

K944049OXYGEN MOUTHGUARDEndovations, Inc.K933537ENCOMPAS COMFORT BLOCK # 0B-10Encompas Unlimited, Inc.K924764OVERTUBE FOR ENDSCOPIC LIGATORSuperior Healthcare Group, Inc.K914978OXYGUARDStantex Pty , Ltd.K896691BITE BLOCKEndoscopix

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.