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FDA 510(k)

KSEA UNIDRIVE II/II PLUS AND ENT ACCESSORIES

K-Number: K003994 · 2001-04-13

ApplicantKARL STORZ Endoscopy-America, Inc.
Decision Date2001-04-13
Product CodeERL
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

KSEA UNIDRIVE II/II PLUS AND ENT 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 2001-04-13 under 510(k) number K003994. 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 II/II PLUS AND ENT ACCESSORIES?

KSEA UNIDRIVE II/II PLUS AND ENT ACCESSORIES is a medical device that received FDA 510(k) clearance on 2001-04-13. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K003994.

When did KSEA UNIDRIVE II/II PLUS AND ENT ACCESSORIES receive FDA 510(k) clearance?

KSEA UNIDRIVE II/II PLUS AND ENT ACCESSORIES received FDA 510(k) clearance on 2001-04-13, under 510(k) number K003994.

Who is the listed applicant for KSEA UNIDRIVE II/II PLUS AND ENT 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 II/II PLUS AND ENT ACCESSORIES?

The FDA product code for KSEA UNIDRIVE II/II PLUS AND ENT ACCESSORIES is ERL.

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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.

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Related Devices (Code: ERL)

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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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