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)

SPEC 5* SUPRAPUBIC CATHETER

K-Number: K881097 · 1988-06-03

ApplicantPorges Corp.
Decision Date1988-06-03
Product CodeKOB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SPEC 5* SUPRAPUBIC CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Porges Corp.. It received FDA 510(k) clearance on 1988-06-03 under 510(k) number K881097. 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 SPEC 5* SUPRAPUBIC CATHETER?

SPEC 5* SUPRAPUBIC CATHETER is a medical device that received FDA 510(k) clearance on 1988-06-03. The listed applicant is Porges Corp.. The 510(k) number is K881097.

When did SPEC 5* SUPRAPUBIC CATHETER receive FDA 510(k) clearance?

SPEC 5* SUPRAPUBIC CATHETER received FDA 510(k) clearance on 1988-06-03, under 510(k) number K881097.

Who is the listed applicant for SPEC 5* SUPRAPUBIC CATHETER?

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

What is the FDA product code for SPEC 5* SUPRAPUBIC CATHETER?

The FDA product code for SPEC 5* SUPRAPUBIC 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 Porges 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.

K900269PORGES DORMIA 3 FR FLAT WIRE BASKET STONE DISLODGEK900031MODIFIED PEDIATRIC SILICONE FOLEY CATHETERSK896505PORGES UNIVERSAL HANDLESK896503PORGES ERCP CATHETERSK896425PORGES CYTOLOGY BRUSHESK896507PORGES DIATHERMY SNARE

View all 18 devices →

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.

↑