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FDA 510(k)

VANCE PERCUTANEOUS MALECOT NEPHROSTOMY

K-Number: K810368 · 1981-03-20

ApplicantVance Products, Inc.
Decision Date1981-03-20
Product CodeKOB
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VANCE PERCUTANEOUS MALECOT NEPHROSTOMY is the device name listed in this FDA 510(k) record. The listed applicant is Vance Products, Inc.. It received FDA 510(k) clearance on 1981-03-20 under 510(k) number K810368. 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 VANCE PERCUTANEOUS MALECOT NEPHROSTOMY?

VANCE PERCUTANEOUS MALECOT NEPHROSTOMY is a medical device that received FDA 510(k) clearance on 1981-03-20. The listed applicant is Vance Products, Inc.. The 510(k) number is K810368.

When did VANCE PERCUTANEOUS MALECOT NEPHROSTOMY receive FDA 510(k) clearance?

VANCE PERCUTANEOUS MALECOT NEPHROSTOMY received FDA 510(k) clearance on 1981-03-20, under 510(k) number K810368.

Who is the listed applicant for VANCE PERCUTANEOUS MALECOT NEPHROSTOMY?

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

What is the FDA product code for VANCE PERCUTANEOUS MALECOT NEPHROSTOMY?

The FDA product code for VANCE PERCUTANEOUS MALECOT NEPHROSTOMY is KOB.

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Other records listing Vance Products, 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.

K820313VPI-FAIR URETHRAL STENTK812995VANCE-JACOBELLIS MICROHEMATURIA CATHETERK813278VPI URETERAL DILATATION BALLON CATHETERK812785VANCE-AMBROSE RESECTOSCOPE FORCEPSK812057VANCE CYSTOSCOPICK811833VNACE FASCIAL DILATOR SET

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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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