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)

AUGUSTINE GUIDE KIT WITH GAUZE SPONGE

K-Number: K914168 · 1991-10-07

ApplicantAugustine Medical, Inc.
Decision Date1991-10-07
Product CodeCCW
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AUGUSTINE GUIDE KIT WITH GAUZE SPONGE is the device name listed in this FDA 510(k) record. The listed applicant is Augustine Medical, Inc.. It received FDA 510(k) clearance on 1991-10-07 under 510(k) number K914168. The device is classified under product code CCW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUGUSTINE GUIDE KIT WITH GAUZE SPONGE?

AUGUSTINE GUIDE KIT WITH GAUZE SPONGE is a medical device that received FDA 510(k) clearance on 1991-10-07. The listed applicant is Augustine Medical, Inc.. The 510(k) number is K914168.

When did AUGUSTINE GUIDE KIT WITH GAUZE SPONGE receive FDA 510(k) clearance?

AUGUSTINE GUIDE KIT WITH GAUZE SPONGE received FDA 510(k) clearance on 1991-10-07, under 510(k) number K914168.

Who is the listed applicant for AUGUSTINE GUIDE KIT WITH GAUZE SPONGE?

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

What is the FDA product code for AUGUSTINE GUIDE KIT WITH GAUZE SPONGE?

The FDA product code for AUGUSTINE GUIDE KIT WITH GAUZE SPONGE is CCW.

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 Augustine Medical, 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.

K021473BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMK020077MODIFICATION TO AUGUSTINE MEDICAL WOUND CARE SYSTEM, MODEL 68XXXK001149AUGUSTINE MEDICAL BAIR HUUGER, MODEL 750 TOTAL TEMPERATURE MANAGEMENT SYSTEM-(MODEL 750 WARMING UNIT, BAIR HUGGER BLANKK973741BAIR HUGGER BLOOD/FLUID WARMERK964673BAIR HUGGER MODEL 630 CARDIAC BLANKETK963293AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXX

View all 25 devices →

Related Devices (Code: CCW)

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.

K191602APA Oxy BladeVenner Medical (Singapore) Pte, Ltd.K163412Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL)Girgis Scope, LLCK121378AIRTRAQ SP AIRTRAQ AVANTProdol Meditec , Ltd.K063477NOVAMED MRI CONDITIONAL LARYNGOSCOPE SETNovamed, LLCK062523TRU-MR LARYNGOSCOPE SETTruphatek International, Ltd.K062230MR FIBER OPTIC INTUBATING LARYNGOSCOPE HANDLE, SHORT, MODEL 310002Minrad, 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.

↑