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FDA 510(k)

SIMPLASTIC SUPRA PUBIC CATHETER

K-Number: K852200 · 1985-08-07

ApplicantFranklin Medical USA, Inc.
Decision Date1985-08-07
Product CodeKOB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SIMPLASTIC SUPRA PUBIC CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Franklin Medical USA, Inc.. It received FDA 510(k) clearance on 1985-08-07 under 510(k) number K852200. The device is classified under product code KOB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIMPLASTIC SUPRA PUBIC CATHETER?

SIMPLASTIC SUPRA PUBIC CATHETER is a medical device that received FDA 510(k) clearance on 1985-08-07. The listed applicant is Franklin Medical USA, Inc.. The 510(k) number is K852200.

When did SIMPLASTIC SUPRA PUBIC CATHETER receive FDA 510(k) clearance?

SIMPLASTIC SUPRA PUBIC CATHETER received FDA 510(k) clearance on 1985-08-07, under 510(k) number K852200.

Who is the listed applicant for SIMPLASTIC SUPRA PUBIC CATHETER?

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

What is the FDA product code for SIMPLASTIC SUPRA PUBIC CATHETER?

The FDA product code for SIMPLASTIC SUPRA PUBIC CATHETER is KOB.

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 Franklin Medical USA, 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.

K931488KSF SPINAL FIXATORK884589FRANTZ MEDICAL SHARPS COLLECTORK862478HAYES VAGINAL SHIELD

Related Devices (Code: KOB)

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.

K240514AMT Low-Profile Suprapubic Catheter & Drainage SetApplied Medical Technology, Inc.K181097Cook Cystostomy Catheter SetCook IncorporatedK182709One-Step Suprapubic IntroducerCook IncorporatedK182066O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer SetCook IncorporatedK120127SWAN VALLEY MEDICAL TRANURETHRAL SUPRAPUBIC ENDO-CYSTOSTOMY (T-SPEC) SURGICAL SYSTEMSwan Valley Medical, IncorporatedK014002ALL SILICONE SUPRA-PUBIA CATHETER, MODELS 4880/4890Fortune Medical Instrument 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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