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FDA 510(k)

SINGLE CANNULA EXTENDED APPLICATOR

K-Number: K102563 · 2011-03-15

ApplicantMicromedics, Inc.
Decision Date2011-03-15
Product CodeKYZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SINGLE CANNULA EXTENDED APPLICATOR is the device name listed in this FDA 510(k) record. The listed applicant is Micromedics, Inc.. It received FDA 510(k) clearance on 2011-03-15 under 510(k) number K102563. The device is classified under product code KYZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SINGLE CANNULA EXTENDED APPLICATOR?

SINGLE CANNULA EXTENDED APPLICATOR is a medical device that received FDA 510(k) clearance on 2011-03-15. The listed applicant is Micromedics, Inc.. The 510(k) number is K102563.

When did SINGLE CANNULA EXTENDED APPLICATOR receive FDA 510(k) clearance?

SINGLE CANNULA EXTENDED APPLICATOR received FDA 510(k) clearance on 2011-03-15, under 510(k) number K102563.

Who is the listed applicant for SINGLE CANNULA EXTENDED APPLICATOR?

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

What is the FDA product code for SINGLE CANNULA EXTENDED APPLICATOR?

The FDA product code for SINGLE CANNULA EXTENDED APPLICATOR is KYZ.

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Other records listing Micromedics, 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.

K241739Endoscopic Applicator, 41 cmK123847MALLEABLE TIP ENDOSCOPIC APPLICATORK122526360 GAS ASSISTED ENDOSCOPIC APPLICATORK120608ENDOSCOPIC APPLICATORK100754GRAFT DELIVERY SYSTEM MODEL SA-6115K073401EARPOPPER, MODEL EP-2000, EP-2100, EP-3000

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Related Devices (Code: KYZ)

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.

K201877OtoSet- Ear Cleaning SystemSafkan, Inc.K092022TISSU TRANS HARVEST TUBINGShippert Medical Technologies Corp.K050797TISSU-TRANSShippert Medical Technologies Corp.K991254QS DELIVERY SYSTEMSub-Q, Inc.K982435IRRIGATION SYRINGE KITSub-Q, Inc.K974288ZEROWET SPLASHIELDZerowet, Inc.

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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