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FDA 510(k)

ENDOMAT LC PUMP, MODEL 20 3303 20

K-Number: K031457 · 2004-04-28

ApplicantKARL STORZ Endoscopy-America, Inc.
Decision Date2004-04-28
Product CodeOCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ENDOMAT LC PUMP, MODEL 20 3303 20 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 2004-04-28 under 510(k) number K031457. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDOMAT LC PUMP, MODEL 20 3303 20?

ENDOMAT LC PUMP, MODEL 20 3303 20 is a medical device that received FDA 510(k) clearance on 2004-04-28. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K031457.

When did ENDOMAT LC PUMP, MODEL 20 3303 20 receive FDA 510(k) clearance?

ENDOMAT LC PUMP, MODEL 20 3303 20 received FDA 510(k) clearance on 2004-04-28, under 510(k) number K031457.

Who is the listed applicant for ENDOMAT LC PUMP, MODEL 20 3303 20?

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 ENDOMAT LC PUMP, MODEL 20 3303 20?

The FDA product code for ENDOMAT LC PUMP, MODEL 20 3303 20 is OCX.

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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: OCX)

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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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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