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FDA 510(k)

Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and Ovoid Applicator Set, Kobold Vaginal Cylinder Applicator Set, Kobold Miami Cylinder Applicator Set

K-Number: K160610 · 2017-02-13

ApplicantKobold, LLC
Decision Date2017-02-13
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and Ovoid Applicator Set, Kobold Vaginal Cylinder Applicator Set, Kobold Miami Cylinder Applicator Set is a medical device manufactured by Kobold, LLC. It received FDA 510(k) clearance on 2017-02-13 under approval number K160610. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and Ovoid Applicator Set, Kobold Vaginal Cylinder Applicator Set, Kobold Miami Cylinder Applicator Set?

Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and Ovoid Applicator Set, Kobold Vaginal Cylinder Applicator Set, Kobold Miami Cylinder Applicator Set is a medical device that received FDA 510(k) clearance on 2017-02-13. It is manufactured by Kobold, LLC. The 510(k) number is K160610.

When was Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and Ovoid Applicator Set, Kobold Vaginal Cylinder Applicator Set, Kobold Miami Cylinder Applicator Set approved by the FDA?

Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and Ovoid Applicator Set, Kobold Vaginal Cylinder Applicator Set, Kobold Miami Cylinder Applicator Set received FDA 510(k) clearance on 2017-02-13, under approval number K160610.

What company makes Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and Ovoid Applicator Set, Kobold Vaginal Cylinder Applicator Set, Kobold Miami Cylinder Applicator Set?

Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and Ovoid Applicator Set, Kobold Vaginal Cylinder Applicator Set, Kobold Miami Cylinder Applicator Set is manufactured by Kobold, LLC.

What is the FDA product code for Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and Ovoid Applicator Set, Kobold Vaginal Cylinder Applicator Set, Kobold Miami Cylinder Applicator Set?

The FDA product code for Kobold Fletcher-model Tandem and Ovoid Applicator Set, Kobold Henschke-model Tandem and Ovoid Applicator Set, Kobold Vaginal Cylinder Applicator Set, Kobold Miami Cylinder Applicator Set is JAQ.

Related Clinical Trials

NCT07409545 Autonomic Nervous System Intrapartum Monitoring to Prevent Neonatal Adverse Outcomes NOT_YET_RECRUITING NCT07394777 An Open Single-armed Investigation to Evaluate the Safety of pHyph Following a Prolonged Treatment Duration in Adult Women With Bacterial Vaginosis COMPLETED NCT06634459 POMEGRANATE Trial: Comparing Reia Pessary Versus Standard of Care Pessary for Pelvic Organ Prolapse Treatment RECRUITING

Other Devices by Kobold, LLC

K170203System, Applicator, Radionuclide, Remote Controlled

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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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