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FDA 510(k)

DND 101

K-Number: K001590 · 2000-08-02

ApplicantUrogyn , Ltd.
Decision Date2000-08-02
Product CodeKNA
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

DND 101 is the device name listed in this FDA 510(k) record. The listed applicant is Urogyn , Ltd.. It received FDA 510(k) clearance on 2000-08-02 under 510(k) number K001590. 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 DND 101?

DND 101 is a medical device that received FDA 510(k) clearance on 2000-08-02. The listed applicant is Urogyn , Ltd.. The 510(k) number is K001590.

When did DND 101 receive FDA 510(k) clearance?

DND 101 received FDA 510(k) clearance on 2000-08-02, under 510(k) number K001590.

Who is the listed applicant for DND 101?

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

What is the FDA product code for DND 101?

The FDA product code for DND 101 is KNA.

Other records listing Urogyn , Ltd. 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.

K014248DND 202 MANUAL UROLOGICAL DIGITAL NEEDLE DRIVER

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.

K102141COOK WORD BARTHOLIN GLAND CATHETER (FINAL TRADE NAME NOT YET DETERMINED)Cook Urological, Inc.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/Gyn

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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