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)

DRAINAGE TUBE RESTRAINT/WOUND COVER

K-Number: K905766 · 1991-03-06

ApplicantM. Imonti and Associates Inc.,
Decision Date1991-03-06
Product CodeGBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DRAINAGE TUBE RESTRAINT/WOUND COVER is the device name listed in this FDA 510(k) record. The listed applicant is M. Imonti and Associates Inc.,. It received FDA 510(k) clearance on 1991-03-06 under 510(k) number K905766. The device is classified under product code GBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DRAINAGE TUBE RESTRAINT/WOUND COVER?

DRAINAGE TUBE RESTRAINT/WOUND COVER is a medical device that received FDA 510(k) clearance on 1991-03-06. The listed applicant is M. Imonti and Associates Inc.,. The 510(k) number is K905766.

When did DRAINAGE TUBE RESTRAINT/WOUND COVER receive FDA 510(k) clearance?

DRAINAGE TUBE RESTRAINT/WOUND COVER received FDA 510(k) clearance on 1991-03-06, under 510(k) number K905766.

Who is the listed applicant for DRAINAGE TUBE RESTRAINT/WOUND COVER?

The FDA 510(k) record lists M. Imonti and Associates Inc., as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DRAINAGE TUBE RESTRAINT/WOUND COVER?

The FDA product code for DRAINAGE TUBE RESTRAINT/WOUND COVER is GBX.

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

Other records listing M. Imonti and Associates Inc., 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.

K950800PRO-PAK FOR OMS DIPLOMATEK950799PRO-VITK933627PHACOFRAGMENTOR TIPK933503PRO-PHACO HANDPIECEK924551ENDO TRACHEA TUBE FIXATION

Related Devices (Code: GBX)

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.

K082725GRAFTGUARD PRESSURE CONTROLLING SYRINGEMaquet Cardiovascular, LLCK052286DEUTSCH ANTI-BLOCKAGE WOUND DRAINThe Catheter Exchange, Inc.K043515GRAFTSAVERVescare, Inc.K013417MISONIX IRRIGATION SYSTEM MOEDL BC20PMisonix, Inc.K000704DMC SAPHENOUS VEIN DISTENTION SYSTEM (SVDS)Dmc Medical, Ltd.K974233LYSONIX IRRIGATION SYSTEMLysonix, 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.

↑