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FDA 510(k)

PERCUTANEOUS PIGTAIL SUPRAPUBLIC CATHETER SET

K-Number: K852287 · 1985-08-08

ApplicantCook Ob/Gyn
Decision Date1985-08-08
Product CodeKOB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PERCUTANEOUS PIGTAIL SUPRAPUBLIC CATHETER SET is the device name listed in this FDA 510(k) record. The listed applicant is Cook Ob/Gyn. It received FDA 510(k) clearance on 1985-08-08 under 510(k) number K852287. 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 PERCUTANEOUS PIGTAIL SUPRAPUBLIC CATHETER SET?

PERCUTANEOUS PIGTAIL SUPRAPUBLIC CATHETER SET is a medical device that received FDA 510(k) clearance on 1985-08-08. The listed applicant is Cook Ob/Gyn. The 510(k) number is K852287.

When did PERCUTANEOUS PIGTAIL SUPRAPUBLIC CATHETER SET receive FDA 510(k) clearance?

PERCUTANEOUS PIGTAIL SUPRAPUBLIC CATHETER SET received FDA 510(k) clearance on 1985-08-08, under 510(k) number K852287.

Who is the listed applicant for PERCUTANEOUS PIGTAIL SUPRAPUBLIC CATHETER SET?

The FDA 510(k) record lists Cook Ob/Gyn as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PERCUTANEOUS PIGTAIL SUPRAPUBLIC CATHETER SET?

The FDA product code for PERCUTANEOUS PIGTAIL SUPRAPUBLIC CATHETER SET is KOB.

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Other records listing Cook Ob/Gyn 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.

K062438BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500K030441SYDNEY IVF BLASTOCYST CRYOPRESERVATION KIT AND SYDNEY IVF BLASTOCYST THAW KITK023850SYDNEY IVF EMBRYO BIOPSY MEDIUMK013597TAMPONADE UTERINE BALLOON CATHETER SETK002385COOK IVF FOLLICLE FLUSHING BUFFER, COOK IVF OOCYTE WASH BUFFER, COOK IVF FERTILIZATION MEDIUM, COOK IVF CLEAVAGE MEDIUM,K002383COOK IVF SPERM BUFFER, COOK IVF SPERM MEDIUM, AND COOK IVF SPERM GRADIENT KIT

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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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