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FDA 510(k)

PEDIATRIC PERCUTANEOUS NEPHROSTOMY SETS

K-Number: K854909 · 1986-01-24

ApplicantAngiomed U.S., Inc.
Decision Date1986-01-24
Product CodeGBO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PEDIATRIC PERCUTANEOUS NEPHROSTOMY SETS is the device name listed in this FDA 510(k) record. The listed applicant is Angiomed U.S., Inc.. It received FDA 510(k) clearance on 1986-01-24 under 510(k) number K854909. The device is classified under product code GBO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PEDIATRIC PERCUTANEOUS NEPHROSTOMY SETS?

PEDIATRIC PERCUTANEOUS NEPHROSTOMY SETS is a medical device that received FDA 510(k) clearance on 1986-01-24. The listed applicant is Angiomed U.S., Inc.. The 510(k) number is K854909.

When did PEDIATRIC PERCUTANEOUS NEPHROSTOMY SETS receive FDA 510(k) clearance?

PEDIATRIC PERCUTANEOUS NEPHROSTOMY SETS received FDA 510(k) clearance on 1986-01-24, under 510(k) number K854909.

Who is the listed applicant for PEDIATRIC PERCUTANEOUS NEPHROSTOMY SETS?

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

What is the FDA product code for PEDIATRIC PERCUTANEOUS NEPHROSTOMY SETS?

The FDA product code for PEDIATRIC PERCUTANEOUS NEPHROSTOMY SETS is GBO.

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Other records listing Angiomed U.S., 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.

K874771ANGIOMED INTRODUCING SETSK874585ANGIOMED OSTY-CUT BONE BIOPSY NEEDLEK864225ANGIOMED URETERAL D&M SETS/URETEROSCOPY GUID STENTK863386VESICO SUPRAPUBIC BLADDER DRAINAGE & EXCHANGE SETSK862805ANGIOMED VAC-U-CUT BIOPSY NEEDLEK863446ANGIOMED HIGH PRESSURE CONNECTORS

View all 24 devices →

Related Devices (Code: GBO)

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.

K041995MODIFICATION TO: GP GENERAL PURPOSE DRAINAGE CATHETER, MINI-PIG DRAINAGE CATHETER, NEPHROSTOMY CATHETER, BILIARYUresil, LLCK021632GP GENERAL PURPOSE DRAINAGE CATHETER; MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL; GP GENERAL PURPOSE DRAINAGE CUresil, L.P.K912109URESIL GENERAL PURPOSE DRAINAGE CATHETERUresil Corp.K854906PERCUTANEOUS NEPHROSTOMY SETS (OTTO)Angiomed U.S., Inc.K854907PERCUTANEOUS NEPHROSTOMY SETS (GUNTHER)Angiomed U.S., Inc.K854911PERCUTANEOUS NEPHROSTOMY SETS (SCHULLER)Angiomed U.S., Inc.

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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