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FDA 510(k)

FLEXIBLE FIBER OPTIC ENDOSCOPE

K-Number: K922826 · 1993-02-19

ApplicantOptimed Technologies, Inc.
Decision Date1993-02-19
Product CodeFGA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FLEXIBLE FIBER OPTIC ENDOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Optimed Technologies, Inc.. It received FDA 510(k) clearance on 1993-02-19 under 510(k) number K922826. The device is classified under product code FGA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLEXIBLE FIBER OPTIC ENDOSCOPE?

FLEXIBLE FIBER OPTIC ENDOSCOPE is a medical device that received FDA 510(k) clearance on 1993-02-19. The listed applicant is Optimed Technologies, Inc.. The 510(k) number is K922826.

When did FLEXIBLE FIBER OPTIC ENDOSCOPE receive FDA 510(k) clearance?

FLEXIBLE FIBER OPTIC ENDOSCOPE received FDA 510(k) clearance on 1993-02-19, under 510(k) number K922826.

Who is the listed applicant for FLEXIBLE FIBER OPTIC ENDOSCOPE?

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

What is the FDA product code for FLEXIBLE FIBER OPTIC ENDOSCOPE?

The FDA product code for FLEXIBLE FIBER OPTIC ENDOSCOPE is FGA.

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Other records listing Optimed Technologies, 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.

K972520OPTIVIEWK955274BOOSTER LITE 3 MOTORIZED SCOOTERK955275BOOSTER TROPHY 5 MOTORIZED SCOOTERK955276BOOSTER LITE 4 MOTORIZED SCOOTERK943598FLEXIBLE FIBER OPTIC LAPAROSCOPESK926597LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

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Related Devices (Code: FGA)

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.

K232370Percutaneous Nephroscope SystemKarl Storz SE & CO. KGK151308Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope SetSchoelly Fiberoptic GmbHK072594GYRUS ACMI IPN-2505, INVISIO SMITH PERCUTANEOUS NEPHROSCOPE SYSTEMGyrus Acmi, Inc.K994223NEPHROSCOPE, 12 DEGREES; DIAPHRAGM VALVE; IRRIGATION ATTACHMENT; NEPHROSCOPE, 20 DEGREE, STRAIGHT VIEW; NEPHROSCOPE, 20Richard Wolf Medical Instruments Corp.K950433KARL STORZ ENDOPYELOTOMY SET FOR ENDOSCOPIC UROLOGY PROCEDURESKARL STORZ Endoscopy-America, Inc.K940594KARL STORZ ADULT & PEDIATRIC NEPHROSCOPEKARL 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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