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FDA 510(k)

MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL

K-Number: K122434 · 2012-10-31

ApplicantMedtronic Xomed
Decision Date2012-10-31
Product CodeNHB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Xomed. It received FDA 510(k) clearance on 2012-10-31 under 510(k) number K122434. The device is classified under product code NHB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL?

MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL is a medical device that received FDA 510(k) clearance on 2012-10-31. The listed applicant is Medtronic Xomed. The 510(k) number is K122434.

When did MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL receive FDA 510(k) clearance?

MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL received FDA 510(k) clearance on 2012-10-31, under 510(k) number K122434.

Who is the listed applicant for MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL?

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

What is the FDA product code for MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL?

The FDA product code for MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL is NHB.

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Other records listing Medtronic Xomed 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.

K202623Novapak Nasal Sinus Packing and StentK031510NIM-SPINEK002972MEROGEL CONTROL GEL ENT SURGICAL DRESSINGK002224XPS 3000 SYSTEMK000728MEDTRONIC SOLAN FIBEROPTIC CORNEAL LIGHT PROBEK990793ACCUGUIDE MUSCLE INJECTION MONITOR

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Related Devices (Code: NHB)

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.

K260620SeptAlign (SPLN001)Spirair, Inc.K251790SeptAlignSpirair, Inc.K233569SeptAlignSpirair, Inc.K223167Spirair Nasal Septal StrapSpirair, Inc.K210411PosiSep EAR Fragmentable Ear DressingHemostasis, LLCK192661LATERA Absorbable Nasal Implant SystemEntellus Medical, Inc. (Aka Stryker Ent)

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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