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FDA 510(k)

ESOPHAGOSCOPE AND ACCESSORIES

K-Number: K943667 · 1994-08-18

ApplicantKARL STORZ Endoscopy-America, Inc.
Decision Date1994-08-18
Product CodeEOX
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ESOPHAGOSCOPE AND 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 1994-08-18 under 510(k) number K943667. 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 ESOPHAGOSCOPE AND ACCESSORIES?

ESOPHAGOSCOPE AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 1994-08-18. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K943667.

When did ESOPHAGOSCOPE AND ACCESSORIES receive FDA 510(k) clearance?

ESOPHAGOSCOPE AND ACCESSORIES received FDA 510(k) clearance on 1994-08-18, under 510(k) number K943667.

Who is the listed applicant for ESOPHAGOSCOPE AND 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 ESOPHAGOSCOPE AND ACCESSORIES?

The FDA product code for ESOPHAGOSCOPE AND ACCESSORIES is EOX.

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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

View all 355 devices →

Related Devices (Code: EOX)

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.

K233142EndoSign® Cell collection device (ES-CYT-102)Cyted LimitedK230339EsoCheck Cell Collection DeviceLucid Diagnostics, Inc.K223072PENTAX Medical Video Esophagoscope EE17-J10Pentax of America, Inc.K222366EsoCheck Cell Collection DeviceLucid Diagnostics, Inc.K203450EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata)Capnostics, LLCK210137EsoCheck Cell Collection DeviceLucid Diagnostics, Inc.

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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