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)

OMNISORB II, NONWOVEN SPONGE, STERILE AND NON

K-Number: K931610 · 1993-06-24

ApplicantOmni Mfg., Inc.
Decision Date1993-06-24
Product CodeNAB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OMNISORB II, NONWOVEN SPONGE, STERILE AND NON is the device name listed in this FDA 510(k) record. The listed applicant is Omni Mfg., Inc.. It received FDA 510(k) clearance on 1993-06-24 under 510(k) number K931610. The device is classified under product code NAB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OMNISORB II, NONWOVEN SPONGE, STERILE AND NON?

OMNISORB II, NONWOVEN SPONGE, STERILE AND NON is a medical device that received FDA 510(k) clearance on 1993-06-24. The listed applicant is Omni Mfg., Inc.. The 510(k) number is K931610.

When did OMNISORB II, NONWOVEN SPONGE, STERILE AND NON receive FDA 510(k) clearance?

OMNISORB II, NONWOVEN SPONGE, STERILE AND NON received FDA 510(k) clearance on 1993-06-24, under 510(k) number K931610.

Who is the listed applicant for OMNISORB II, NONWOVEN SPONGE, STERILE AND NON?

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

What is the FDA product code for OMNISORB II, NONWOVEN SPONGE, STERILE AND NON?

The FDA product code for OMNISORB II, NONWOVEN SPONGE, STERILE AND NON is NAB.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Related Devices (Code: NAB)

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.

K946015IVALON EXTERNAL SPONGEIvalonK940755ISOLYER (4X4, 8PLY)Isolyer Co.K925590MULTI-TRAUMA DRESSINGGam Industries, Inc.K926072K-BAND AND K-CREPEParema , Ltd.K915591STERILE GAUZE PADSEagle Medical, Inc.K924650GAUZE SPONGESDav-Mar Medical Products, Inc.

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.

↑