FDA 510(k)

KARL STORZ UNIPOLAR BALL, NEEDLE, LOOP ELECTRODES

K-Number: K944795 · 1994-12-21

ApplicantKARL STORZ Endoscopy-America, Inc.

Decision Date1994-12-21

Product CodeFAS

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

KARL STORZ UNIPOLAR BALL, NEEDLE, LOOP ELECTRODES 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 1994-12-21 under 510(k) number K944795. The device is classified under product code FAS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KARL STORZ UNIPOLAR BALL, NEEDLE, LOOP ELECTRODES?

KARL STORZ UNIPOLAR BALL, NEEDLE, LOOP ELECTRODES is a medical device that received FDA 510(k) clearance on 1994-12-21. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K944795.

When did KARL STORZ UNIPOLAR BALL, NEEDLE, LOOP ELECTRODES receive FDA 510(k) clearance?

KARL STORZ UNIPOLAR BALL, NEEDLE, LOOP ELECTRODES received FDA 510(k) clearance on 1994-12-21, under 510(k) number K944795.

Who is the listed applicant for KARL STORZ UNIPOLAR BALL, NEEDLE, LOOP ELECTRODES?

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 KARL STORZ UNIPOLAR BALL, NEEDLE, LOOP ELECTRODES?

The FDA product code for KARL STORZ UNIPOLAR BALL, NEEDLE, LOOP ELECTRODES is FAS.

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Other records listing KARL STORZ Endoscopy-America, Inc. as applicant

K252624KARL STORZ Laryngoscopes and Accessories K240506KARL STORZ Holders K223885HOPKINS Telescopes K230359KOH 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 System K223923HOPKINS Telescopes

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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.