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)

ABDOVAC (TM), BELLOVAC (TM) AND EXUDRAIN

K-Number: K920819 · 1993-03-24

ApplicantAstra Meditec AB
Decision Date1993-03-24
Product CodeGCY
Advisory CommitteeSU
DecisionUnknown

Device Summary

ABDOVAC (TM), BELLOVAC (TM) AND EXUDRAIN is the device name listed in this FDA 510(k) record. The listed applicant is Astra Meditec AB. It received FDA 510(k) clearance on 1993-03-24 under 510(k) number K920819. The device is classified under product code GCY. It was reviewed by the SU advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the ABDOVAC (TM), BELLOVAC (TM) AND EXUDRAIN?

ABDOVAC (TM), BELLOVAC (TM) AND EXUDRAIN is a medical device that received FDA 510(k) clearance on 1993-03-24. The listed applicant is Astra Meditec AB. The 510(k) number is K920819.

When did ABDOVAC (TM), BELLOVAC (TM) AND EXUDRAIN receive FDA 510(k) clearance?

ABDOVAC (TM), BELLOVAC (TM) AND EXUDRAIN received FDA 510(k) clearance on 1993-03-24, under 510(k) number K920819.

Who is the listed applicant for ABDOVAC (TM), BELLOVAC (TM) AND EXUDRAIN?

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

What is the FDA product code for ABDOVAC (TM), BELLOVAC (TM) AND EXUDRAIN?

The FDA product code for ABDOVAC (TM), BELLOVAC (TM) AND EXUDRAIN 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.

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 Astra Meditec AB 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.

K896750LOFRIC(R), LOFRIC(R) CATH-KITK882578ASTRA DENTAL IMPLANT SYSTEM

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.

K972703REDYROB-CLOSED WOUND DRAINAGE SYSTEMB.Braun Medical, Inc.K971036ODONTIT AUTOGENOUS BONE COLLECTION DEVICEInterpore Intl.K963839CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500Cordis Corp.K960099PENROSE DRAIN MODELS 6001 - 6007Sil-Med Corp.K950754MACRO SUCTION TUBE MODEL NO 10061Dlp, Inc.K936223PRESSURE IRRIGATING SYSTEMLevel 1 Technologies, 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.

↑