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FDA 510(k)

KSEA ENDOSCOPES FOR DENTAL PROCEDURES

K-Number: K982658 · 1998-10-15

ApplicantKARL STORZ Endoscopy-America, Inc.
Decision Date1998-10-15
Product CodeEIA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KSEA ENDOSCOPES FOR DENTAL PROCEDURES 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 1998-10-15 under 510(k) number K982658. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KSEA ENDOSCOPES FOR DENTAL PROCEDURES?

KSEA ENDOSCOPES FOR DENTAL PROCEDURES is a medical device that received FDA 510(k) clearance on 1998-10-15. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K982658.

When did KSEA ENDOSCOPES FOR DENTAL PROCEDURES receive FDA 510(k) clearance?

KSEA ENDOSCOPES FOR DENTAL PROCEDURES received FDA 510(k) clearance on 1998-10-15, under 510(k) number K982658.

Who is the listed applicant for KSEA ENDOSCOPES FOR DENTAL PROCEDURES?

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 ENDOSCOPES FOR DENTAL PROCEDURES?

The FDA product code for KSEA ENDOSCOPES FOR DENTAL PROCEDURES is EIA.

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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: EIA)

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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