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FDA 510(k)

KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES

K-Number: K053262 · 2005-12-19

ApplicantKARL STORZ Endoscopy-America, Inc.
Decision Date2005-12-19
Product CodeERL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is KARL STORZ Endoscopy-America, Inc.. It received FDA 510(k) clearance on 2005-12-19 under 510(k) number K053262. 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 KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES?

KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 2005-12-19. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K053262.

When did KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES receive FDA 510(k) clearance?

KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES received FDA 510(k) clearance on 2005-12-19, under 510(k) number K053262.

Who is the listed applicant for KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES?

The FDA 510(k) record lists KARL STORZ Endoscopy-America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES?

The FDA product code for KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES is ERL.

Related Clinical Trials

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.

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Other records listing KARL STORZ Endoscopy-America, 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.

K252624KARL STORZ Laryngoscopes and AccessoriesK240506KARL STORZ HoldersK223885HOPKINS TelescopesK230359KOH Ultramicro Injection Cannula (26167NN); Suction a. Irrig. Cannula,L. 36cm (37360CP); Suction a. Irrig. Cannula,L. 36cm (37360SC); Suction and Irrig Cannula,l. 36cm (37560LH); Suction a. Irrig. Cannula,L. 30cm (37260LH); KOH Ultramicro Injection Needle (26167NA); Puncture Needle, LUER-lock (26178R); Suction a. Irrig. Cannula,L. 43cm (37460LH); Suction a. Irrig. Cannula,L. 36cm (37360LH); Puncture Needle, dia. 1.6 mm, 36 cm (26175R); Two-Way Stopcock (26167H); Injection Needle, LUER-K223520UNIDRIVE SIII SystemK223923HOPKINS Telescopes

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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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