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FDA 510(k)

SERIES 5000 ENDOSCOPE CONSOLE MODELS 5100 AND 5200

K-Number: K912447 · 1991-09-27

ApplicantMedical Laser, Inc.
Decision Date1991-09-27
Product CodeFET
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SERIES 5000 ENDOSCOPE CONSOLE MODELS 5100 AND 5200 is the device name listed in this FDA 510(k) record. The listed applicant is Medical Laser, Inc.. It received FDA 510(k) clearance on 1991-09-27 under 510(k) number K912447. The device is classified under product code FET. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERIES 5000 ENDOSCOPE CONSOLE MODELS 5100 AND 5200?

SERIES 5000 ENDOSCOPE CONSOLE MODELS 5100 AND 5200 is a medical device that received FDA 510(k) clearance on 1991-09-27. The listed applicant is Medical Laser, Inc.. The 510(k) number is K912447.

When did SERIES 5000 ENDOSCOPE CONSOLE MODELS 5100 AND 5200 receive FDA 510(k) clearance?

SERIES 5000 ENDOSCOPE CONSOLE MODELS 5100 AND 5200 received FDA 510(k) clearance on 1991-09-27, under 510(k) number K912447.

Who is the listed applicant for SERIES 5000 ENDOSCOPE CONSOLE MODELS 5100 AND 5200?

The FDA 510(k) record lists Medical Laser, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SERIES 5000 ENDOSCOPE CONSOLE MODELS 5100 AND 5200?

The FDA product code for SERIES 5000 ENDOSCOPE CONSOLE MODELS 5100 AND 5200 is FET.

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Other records listing Medical Laser, 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.

K913136LASER ENDOSCOPE DISC DECOMPRESSION KITSK912265MEDILASE SEMI-RIGID INSTROD SHEATH SERIES AE1000K912089MODIFIED SERIES 2100 ENDOSCOPESK901464MEDILASE SERIES 2200 ENDOSCOPEK900894MEDILASE SERIES 2100 ENDOSCOPEK900380MEDILASE 5010 ENDOSCOPE CONSOLE

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Related Devices (Code: FET)

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.

K2620794K Camera Head OLYMPUS CH-S700-08-LBOlympus Medical Systems Corp.K261880FUJIFILM Processor EP-8000;Balloon Controller PB-30;Endoscopy Support Program EW10-VM01Fujifilm CorporationK261260HD Camera Head OLYMPUS CH-S200-08-LBOlympus Medical Systems CorporationK251734ProVee Video Processing Unit (PV-003)Proverum LimitedK250462UL UHD-Clear View 4K Camera System (UL-3Chip 4K)Univlabs Technologies Private LimitedK250204Endoscopic Camera SystemShenzhen Sophway Technology Co., Ltd.

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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