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FDA 510(k)

LOWSLEY SUPRAPUBIC TRACTOR

K-Number: K012153 · 2001-09-19

ApplicantCircon Video
Decision Date2001-09-19
Product CodeKOB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LOWSLEY SUPRAPUBIC TRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is Circon Video. It received FDA 510(k) clearance on 2001-09-19 under 510(k) number K012153. 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 LOWSLEY SUPRAPUBIC TRACTOR?

LOWSLEY SUPRAPUBIC TRACTOR is a medical device that received FDA 510(k) clearance on 2001-09-19. The listed applicant is Circon Video. The 510(k) number is K012153.

When did LOWSLEY SUPRAPUBIC TRACTOR receive FDA 510(k) clearance?

LOWSLEY SUPRAPUBIC TRACTOR received FDA 510(k) clearance on 2001-09-19, under 510(k) number K012153.

Who is the listed applicant for LOWSLEY SUPRAPUBIC TRACTOR?

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

What is the FDA product code for LOWSLEY SUPRAPUBIC TRACTOR?

The FDA product code for LOWSLEY SUPRAPUBIC TRACTOR is KOB.

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Other records listing Circon Video 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.

K012758URETEROSCOPE, PEDIATRIC CYSTOURETEROSCOPE, OPERATING PEDIATRIC CYSTOURETEROSCOPE, MODELS MR-9, MR-9L,K011876DOLPHIN II FLUID MANAGEMENT SYSTEM, MODEL DOL-2K011849MICRO-6-SERIES (MR-6, MR-6L) URETEROSCOPES, MRO-6 SERIES (MR-633, MR-642) URETEROSCOPES, MRO-7 SERIES (MRO-733) URETEROSK012929FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735K012951APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPEK012925DUR-8, MODELS DUR-8

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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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