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FDA 510(k)

KSEA POWERSHAVER SYSTEM S2

K-Number: K030009 · 2003-04-02

ApplicantKarl Storz Endoscopy
Decision Date2003-04-02
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

KSEA POWERSHAVER SYSTEM S2 is the device name listed in this FDA 510(k) record. The listed applicant is Karl Storz Endoscopy. It received FDA 510(k) clearance on 2003-04-02 under 510(k) number K030009. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KSEA POWERSHAVER SYSTEM S2?

KSEA POWERSHAVER SYSTEM S2 is a medical device that received FDA 510(k) clearance on 2003-04-02. The listed applicant is Karl Storz Endoscopy. The 510(k) number is K030009.

When did KSEA POWERSHAVER SYSTEM S2 receive FDA 510(k) clearance?

KSEA POWERSHAVER SYSTEM S2 received FDA 510(k) clearance on 2003-04-02, under 510(k) number K030009.

Who is the listed applicant for KSEA POWERSHAVER SYSTEM S2?

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

What is the FDA product code for KSEA POWERSHAVER SYSTEM S2?

The FDA product code for KSEA POWERSHAVER SYSTEM S2 is HRX.

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Other records listing Karl Storz Endoscopy 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.

K043375FISCH TITANIUM MIDDLE EAR PROSTHESESK030848PERFORATED BIOABSORBABLE INTERFERENCE SCREW MEGAFIXK023924AUTOCON II 200 ELECTROSURGICAL GENERATORK023187KSEA SPINOSCOPEK011700MODULITH SLK LITHOTRIPTERK021776KSEA QUADRO SWITCH

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Related Devices (Code: HRX)

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.

K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd.K254103HOPKINS Telescopes for ArthroscopyKarl Storz SE & CO. KGK252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLCK253523Freedom DS™ Decompression SystemSpinal SimplicityK252546VantageTM Lumbar Decompression KitAllevion Medical, LLCK253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)Medimaging Integrated Solution, Inc (Miis)

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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