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FDA 510(k)

COSTELLO-EVERETT LASER CYSTOSCOPE SHEATH

K-Number: K942573 · 1994-07-18

ApplicantRichard Hamer Assoc., Inc.
Decision Date1994-07-18
Product CodeFED
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COSTELLO-EVERETT LASER CYSTOSCOPE SHEATH is the device name listed in this FDA 510(k) record. The listed applicant is Richard Hamer Assoc., Inc.. It received FDA 510(k) clearance on 1994-07-18 under 510(k) number K942573. The device is classified under product code FED. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COSTELLO-EVERETT LASER CYSTOSCOPE SHEATH?

COSTELLO-EVERETT LASER CYSTOSCOPE SHEATH is a medical device that received FDA 510(k) clearance on 1994-07-18. The listed applicant is Richard Hamer Assoc., Inc.. The 510(k) number is K942573.

When did COSTELLO-EVERETT LASER CYSTOSCOPE SHEATH receive FDA 510(k) clearance?

COSTELLO-EVERETT LASER CYSTOSCOPE SHEATH received FDA 510(k) clearance on 1994-07-18, under 510(k) number K942573.

Who is the listed applicant for COSTELLO-EVERETT LASER CYSTOSCOPE SHEATH?

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

What is the FDA product code for COSTELLO-EVERETT LASER CYSTOSCOPE SHEATH?

The FDA product code for COSTELLO-EVERETT LASER CYSTOSCOPE SHEATH is FED.

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Other records listing Richard Hamer Assoc., Inc. as applicant

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Related Devices (Code: FED)

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.

K260512Disposable Ureteral Access SheathYangzhou Fartley Medical Instrument Technology Co., Ltd.K262262Pathfinder Endoscope OvertubeNeptune Medical, Inc.K260410Single Use Ureteral Access SheathZhejiang Chuangxiang Medical Technology Co., Ltd.K261915Navigator™ Flex Ureteral Access Sheath SetBoston Scientific CorporationK260965CVAC Aspiration SystemCalyxo, Inc.K260521ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)Zhuhai Pusen Medical Technology Co., Ltd.

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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