FDA 510(k)

KARL STORZ ENT NEEDLES, TONSIL SYRINGES & NEEDLES

K-Number: K951395 · 1995-05-09

ApplicantKARL STORZ Endoscopy-America, Inc.

Decision Date1995-05-09

Product CodeEOX

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

KARL STORZ ENT NEEDLES, TONSIL SYRINGES & NEEDLES 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 1995-05-09 under 510(k) number K951395. The device is classified under product code EOX. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KARL STORZ ENT NEEDLES, TONSIL SYRINGES & NEEDLES?

KARL STORZ ENT NEEDLES, TONSIL SYRINGES & NEEDLES is a medical device that received FDA 510(k) clearance on 1995-05-09. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K951395.

When did KARL STORZ ENT NEEDLES, TONSIL SYRINGES & NEEDLES receive FDA 510(k) clearance?

KARL STORZ ENT NEEDLES, TONSIL SYRINGES & NEEDLES received FDA 510(k) clearance on 1995-05-09, under 510(k) number K951395.

Who is the listed applicant for KARL STORZ ENT NEEDLES, TONSIL SYRINGES & NEEDLES?

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 ENT NEEDLES, TONSIL SYRINGES & NEEDLES?

The FDA product code for KARL STORZ ENT NEEDLES, TONSIL SYRINGES & NEEDLES is EOX.

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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.