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FDA 510(k)

RUBENSTEIN URETERAL STONE FRAGMENT BRUSH

K-Number: K885168 · 1989-09-08

ApplicantBoston Scientific Corp
Decision Date1989-09-08
Product CodeFGO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RUBENSTEIN URETERAL STONE FRAGMENT BRUSH is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 1989-09-08 under 510(k) number K885168. The device is classified under product code FGO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RUBENSTEIN URETERAL STONE FRAGMENT BRUSH?

RUBENSTEIN URETERAL STONE FRAGMENT BRUSH is a medical device that received FDA 510(k) clearance on 1989-09-08. The listed applicant is Boston Scientific Corp. The 510(k) number is K885168.

When did RUBENSTEIN URETERAL STONE FRAGMENT BRUSH receive FDA 510(k) clearance?

RUBENSTEIN URETERAL STONE FRAGMENT BRUSH received FDA 510(k) clearance on 1989-09-08, under 510(k) number K885168.

Who is the listed applicant for RUBENSTEIN URETERAL STONE FRAGMENT BRUSH?

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

What is the FDA product code for RUBENSTEIN URETERAL STONE FRAGMENT BRUSH?

The FDA product code for RUBENSTEIN URETERAL STONE FRAGMENT BRUSH is FGO.

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Other records listing Boston Scientific Corp as applicant

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Related Devices (Code: FGO)

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.

K001563SCIPRO(TM) FLEXIBLE STONE DISLODGER AND RETRIEVAL SETScion Cardiovascular, Inc.K970121STONE DISLODGER, BASKETBoston Scientific CorpK963750RETRIEVAL SNAREBoston Scientific CorpK962676DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICEUnited States Endoscopy Group, Inc.K951309STONE DISLODGER, BASKETBoston Scientific CorpK933261GRASPING FORCEPSSurgitek

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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