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FDA 510(k)

MODIFIED SERIES 2100 ENDOSCOPES

K-Number: K912089 · 1991-08-12

ApplicantMedical Laser, Inc.
Decision Date1991-08-12
Product CodeODF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MODIFIED SERIES 2100 ENDOSCOPES 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 1991-08-12 under 510(k) number K912089. The device is classified under product code ODF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFIED SERIES 2100 ENDOSCOPES?

MODIFIED SERIES 2100 ENDOSCOPES is a medical device that received FDA 510(k) clearance on 1991-08-12. The listed applicant is Medical Laser, Inc.. The 510(k) number is K912089.

When did MODIFIED SERIES 2100 ENDOSCOPES receive FDA 510(k) clearance?

MODIFIED SERIES 2100 ENDOSCOPES received FDA 510(k) clearance on 1991-08-12, under 510(k) number K912089.

Who is the listed applicant for MODIFIED SERIES 2100 ENDOSCOPES?

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 MODIFIED SERIES 2100 ENDOSCOPES?

The FDA product code for MODIFIED SERIES 2100 ENDOSCOPES is ODF.

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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 AE1000K912447SERIES 5000 ENDOSCOPE CONSOLE MODELS 5100 AND 5200K901464MEDILASE SERIES 2200 ENDOSCOPEK900894MEDILASE SERIES 2100 ENDOSCOPEK900380MEDILASE 5010 ENDOSCOPE CONSOLE

View all 8 devices →

Related Devices (Code: ODF)

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.

K092739MICROENDOSCOPE MODEL S-0001 SINGLE LIGHT SOURCE, MICROENDOSCOPE, MODEL D-0001 DUAL LIGHT SOURCE STERILEC-Link Micro Imaging, Inc.K091962POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200Lumenis, Inc.K090170SPYSCOPE ACCESS AND DELIVERY CATHETERBoston Scientific CorpK052194SPYGLASS DIRECT VISUALIZATION PROBE AND OCULARBoston Scientific CorpK050403SPYGLASS DIRECT VISULATION PROBEBoston Scientific CorpK9633545 STAR MEDICAL ENDOSCOPEFive Star Medical, 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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