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FDA 510(k)

SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW SEMI0RIGID AND FLEXIBLE MANUAL SURGICAL INSTRUM

K-Number: K972979 · 1997-12-11

ApplicantSmith & Nephew, Inc.
Decision Date1997-12-11
Product CodeFBO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW SEMI0RIGID AND FLEXIBLE MANUAL SURGICAL INSTRUM is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 1997-12-11 under 510(k) number K972979. The device is classified under product code FBO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW SEMI0RIGID AND FLEXIBLE MANUAL SURGICAL INSTRUM?

SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW SEMI0RIGID AND FLEXIBLE MANUAL SURGICAL INSTRUM is a medical device that received FDA 510(k) clearance on 1997-12-11. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K972979.

When did SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW SEMI0RIGID AND FLEXIBLE MANUAL SURGICAL INSTRUM receive FDA 510(k) clearance?

SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW SEMI0RIGID AND FLEXIBLE MANUAL SURGICAL INSTRUM received FDA 510(k) clearance on 1997-12-11, under 510(k) number K972979.

Who is the listed applicant for SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW SEMI0RIGID AND FLEXIBLE MANUAL SURGICAL INSTRUM?

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

What is the FDA product code for SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW SEMI0RIGID AND FLEXIBLE MANUAL SURGICAL INSTRUM?

The FDA product code for SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW SEMI0RIGID AND FLEXIBLE MANUAL SURGICAL INSTRUM is FBO.

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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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