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FDA 510(k)

SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT)

K-Number: K012456 · 2001-09-21

ApplicantSodemsystems
Decision Date2001-09-21
Product CodeERL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT) is the device name listed in this FDA 510(k) record. The listed applicant is Sodemsystems. It received FDA 510(k) clearance on 2001-09-21 under 510(k) number K012456. The device is classified under product code ERL. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT)?

SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT) is a medical device that received FDA 510(k) clearance on 2001-09-21. The listed applicant is Sodemsystems. The 510(k) number is K012456.

When did SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT) receive FDA 510(k) clearance?

SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT) received FDA 510(k) clearance on 2001-09-21, under 510(k) number K012456.

Who is the listed applicant for SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT)?

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

What is the FDA product code for SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT)?

The FDA product code for SODEM HIGH SPEED SYSTEM (ELECTRIC) (EAR, NOSE, AND THROAT) is ERL.

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Other records listing Sodemsystems 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.

K023070SODEM HIGH SPEED SYSTEM (PNEUMATIC)K023066DRILL GUIDE ATTACHMENT (PN 3105 DG) OF THE SODEM HIGH SPEED SYSTEM (PNEUMATIC)K012453SODEM HIGH SPEED SYSTEM (ELECTRIC) (GENERAL ORTHOPEDICS & PLASTIC SURGERY)K012457SODEM HIGH SPEED SYSTEM (ELECTRIC) (NEURO/SPINE SURGERY)K993851SODEM PERFORATOR DRIVEK994175MODIFICATION TO SODEM HIGH SPEED SYSTEM FOR NEUROSURGICAL USE

View all 8 devices →

Related Devices (Code: ERL)

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.

K243280Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)W&H Dentalwerk Buermoos GmbHK233958hekaDrillZethon, Ltd.K221184ORiGO SystemBien-Air Surgery SAK213221AMADEO, M-UK1015 (incl. attachments and accessories)W&H Dentalwerk Buermoss GmbHK212650Celeris, Disposable Sinus DebriderGyrus Acmi, Inc.K211490Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000Stryker Corporation

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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