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FDA 510(k)

COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)

K-Number: K102141 · 2011-05-06

ApplicantCook Urological, Inc.
Decision Date2011-05-06
Product CodeKNA
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED) is the device name listed in this FDA 510(k) record. The listed applicant is Cook Urological, Inc.. It received FDA 510(k) clearance on 2011-05-06 under 510(k) number K102141. The device is classified under product code KNA. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)?

COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED) is a medical device that received FDA 510(k) clearance on 2011-05-06. The listed applicant is Cook Urological, Inc.. The 510(k) number is K102141.

When did COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED) receive FDA 510(k) clearance?

COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED) received FDA 510(k) clearance on 2011-05-06, under 510(k) number K102141.

Who is the listed applicant for COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)?

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

What is the FDA product code for COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)?

The FDA product code for COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED) is KNA.

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Other records listing Cook Urological, 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.

K0917673 WAY SILICONE FOLEY BALLOON CATHETERK082939COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400K082066TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLERK082536COOK WIRE GUIDESK082319INJEKT FILIFORM INJECTION NEEDLEK080525COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W

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Related Devices (Code: KNA)

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.

K093904GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETERGlenveigh Surgical, LLCK082939COOK FETAL MEMBRANE MANIPULATOR, MODEL -FMM-122400Cook Urological, Inc.K062438BAKRI POSTPARTUM BALLOON, MODEL J-SOS-100500Cook Ob/GynK060289EPISTAT, V-STAT, MODELS EPISTAT-001-01, V-STAT-001-01Frontline MedicalK013597TAMPONADE UTERINE BALLOON CATHETER SETCook Ob/GynK014248DND 202 MANUAL UROLOGICAL DIGITAL NEEDLE DRIVERUrogyn , 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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