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FDA 510(k)

SCB/STERIS OR-LIGHT INTERFACE BOX

K-Number: K051505 · 2005-08-11

ApplicantKARL STORZ Endoscopy-America, Inc.
Decision Date2005-08-11
Product CodeFTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SCB/STERIS OR-LIGHT INTERFACE BOX 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 2005-08-11 under 510(k) number K051505. The device is classified under product code FTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCB/STERIS OR-LIGHT INTERFACE BOX?

SCB/STERIS OR-LIGHT INTERFACE BOX is a medical device that received FDA 510(k) clearance on 2005-08-11. The listed applicant is KARL STORZ Endoscopy-America, Inc.. The 510(k) number is K051505.

When did SCB/STERIS OR-LIGHT INTERFACE BOX receive FDA 510(k) clearance?

SCB/STERIS OR-LIGHT INTERFACE BOX received FDA 510(k) clearance on 2005-08-11, under 510(k) number K051505.

Who is the listed applicant for SCB/STERIS OR-LIGHT INTERFACE BOX?

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 SCB/STERIS OR-LIGHT INTERFACE BOX?

The FDA product code for SCB/STERIS OR-LIGHT INTERFACE BOX is FTA.

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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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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: FTA)

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.

K112133OASYS SURGICAL LIGHT CONTROLLEROasys HealthcareK102791EASYSUITE SURGICAL LIGHT CONTROL (ESLC)Image Stream Medical, Inc.K081698MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC)Image Stream Medical, Inc.K053321LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVERXodus Medical, Inc.K023704KSEA SCB ACC CONTROLKARL STORZ Endoscopy-America, Inc.K020640KSEA SCB MEDIA CONTROLKARL STORZ Endoscopy-America, 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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