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FDA 510(k)

BIOSOICS SPHINCTER TRAINING SYSTEM

K-Number: K862683 · 1986-11-12

ApplicantBiosonics, Inc.
Decision Date1986-11-12
Product CodeKPN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BIOSOICS SPHINCTER TRAINING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biosonics, Inc.. It received FDA 510(k) clearance on 1986-11-12 under 510(k) number K862683. The device is classified under product code KPN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOSOICS SPHINCTER TRAINING SYSTEM?

BIOSOICS SPHINCTER TRAINING SYSTEM is a medical device that received FDA 510(k) clearance on 1986-11-12. The listed applicant is Biosonics, Inc.. The 510(k) number is K862683.

When did BIOSOICS SPHINCTER TRAINING SYSTEM receive FDA 510(k) clearance?

BIOSOICS SPHINCTER TRAINING SYSTEM received FDA 510(k) clearance on 1986-11-12, under 510(k) number K862683.

Who is the listed applicant for BIOSOICS SPHINCTER TRAINING SYSTEM?

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

What is the FDA product code for BIOSOICS SPHINCTER TRAINING SYSTEM?

The FDA product code for BIOSOICS SPHINCTER TRAINING SYSTEM is KPN.

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 Biosonics, 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.

K882555ANOTRON(R) INCONTINENCE CONTROL SYSTEMK864448THE BIOSONICS CONTINENCE CONTROL SYSTEM CCS(TM)

Related Devices (Code: KPN)

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.

K130951SIMSimavita Pty LimitedK971442HUGHES BLADDER AND BOWEL TRAINING SYSTEM(AD-T-18, MED-18,MED-1,MED-T-1,MEDD-18,MED-38,MED-T-10,MED-T-25,MED-T-5Humed, Inc.K971855POTTY PAL AND FOREVER-DRYDigital Applications, Inc.K962770UROSURGE ACUTRAINERPrinceton Regulatory Assoc.K962416DRYTIME FOR BLADDER CONTROL SILENTBio-Systems ResearchK955338DRYTIME FOR POTTY TRAININGHealth Sense Intl., 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.

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