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FDA 510(k)

SILASTIC NEPHROSTOMY SYSTEM

K-Number: K781664 · 1979-01-22

ApplicantDow Corning Corp. Healthcare Industries Materials
Decision Date1979-01-22
Product CodeGBO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SILASTIC NEPHROSTOMY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Dow Corning Corp. Healthcare Industries Materials. It received FDA 510(k) clearance on 1979-01-22 under 510(k) number K781664. 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 SILASTIC NEPHROSTOMY SYSTEM?

SILASTIC NEPHROSTOMY SYSTEM is a medical device that received FDA 510(k) clearance on 1979-01-22. The listed applicant is Dow Corning Corp. Healthcare Industries Materials. The 510(k) number is K781664.

When did SILASTIC NEPHROSTOMY SYSTEM receive FDA 510(k) clearance?

SILASTIC NEPHROSTOMY SYSTEM received FDA 510(k) clearance on 1979-01-22, under 510(k) number K781664.

Who is the listed applicant for SILASTIC NEPHROSTOMY SYSTEM?

The FDA 510(k) record lists Dow Corning Corp. Healthcare Industries Materials as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SILASTIC NEPHROSTOMY SYSTEM?

The FDA product code for SILASTIC NEPHROSTOMY SYSTEM is GBO.

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Other records listing Dow Corning Corp. Healthcare Industries Materials 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.

K853186SILASTIC INFLATABLE BONE PLUG H.P.K844637WHITESIDE ACRYLIC CEMENT SPACER SLEEVEK850255DOW CORNING WRIGHT TITANIUM WRIST JOINT GROMMETK843995TF-II HIP PROSTHESISK842559WHITESIDE ORTHOLOC TOTAL HIP FEMORALK840357SSA HIP PROSTHESIS

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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.K854907PERCUTANEOUS NEPHROSTOMY SETS (GUNTHER)Angiomed U.S., Inc.K854906PERCUTANEOUS NEPHROSTOMY SETS (OTTO)Angiomed U.S., Inc.K854909PEDIATRIC PERCUTANEOUS NEPHROSTOMY SETSAngiomed 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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