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FDA 510(k)

BIOENTERICS ENDOLUMINA ILLUMINATING BOUGIE

K-Number: K934084 · 1993-12-16

ApplicantBioenterics Corp.
Decision Date1993-12-16
Product CodeHMJ
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

BIOENTERICS ENDOLUMINA ILLUMINATING BOUGIE is the device name listed in this FDA 510(k) record. The listed applicant is Bioenterics Corp.. It received FDA 510(k) clearance on 1993-12-16 under 510(k) number K934084. The device is classified under product code HMJ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOENTERICS ENDOLUMINA ILLUMINATING BOUGIE?

BIOENTERICS ENDOLUMINA ILLUMINATING BOUGIE is a medical device that received FDA 510(k) clearance on 1993-12-16. The listed applicant is Bioenterics Corp.. The 510(k) number is K934084.

When did BIOENTERICS ENDOLUMINA ILLUMINATING BOUGIE receive FDA 510(k) clearance?

BIOENTERICS ENDOLUMINA ILLUMINATING BOUGIE received FDA 510(k) clearance on 1993-12-16, under 510(k) number K934084.

Who is the listed applicant for BIOENTERICS ENDOLUMINA ILLUMINATING BOUGIE?

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

What is the FDA product code for BIOENTERICS ENDOLUMINA ILLUMINATING BOUGIE?

The FDA product code for BIOENTERICS ENDOLUMINA ILLUMINATING BOUGIE is HMJ.

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 Bioenterics Corp. 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.

K002838GASTRIC SUCTION AND DRAINAGE CATHETERK964561ENDOLUMINA II TRANSILLUMINATION SYSTEM 56FR E-5630, 50FR E-5030 AND 40FR E-4020, ENDOLUMINA II DETACHABLE TIPS, 56FR, TAK924753BIOENTRICS ENDOLUMINA ILLUMINATED BOUGIE

Related Devices (Code: HMJ)

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.

K924753BIOENTRICS ENDOLUMINA ILLUMINATED BOUGIEBioenterics Corp.

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.

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