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FDA 510(k)

FLEXIBLE IMMERSIBLE SIGMOIDOSCOPE

K-Number: K892000 · 1989-04-25

ApplicantSchott Fiber Optics, Inc.
Decision Date1989-04-25
Product CodeFAM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FLEXIBLE IMMERSIBLE SIGMOIDOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Schott Fiber Optics, Inc.. It received FDA 510(k) clearance on 1989-04-25 under 510(k) number K892000. The device is classified under product code FAM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLEXIBLE IMMERSIBLE SIGMOIDOSCOPE?

FLEXIBLE IMMERSIBLE SIGMOIDOSCOPE is a medical device that received FDA 510(k) clearance on 1989-04-25. The listed applicant is Schott Fiber Optics, Inc.. The 510(k) number is K892000.

When did FLEXIBLE IMMERSIBLE SIGMOIDOSCOPE receive FDA 510(k) clearance?

FLEXIBLE IMMERSIBLE SIGMOIDOSCOPE received FDA 510(k) clearance on 1989-04-25, under 510(k) number K892000.

Who is the listed applicant for FLEXIBLE IMMERSIBLE SIGMOIDOSCOPE?

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

What is the FDA product code for FLEXIBLE IMMERSIBLE SIGMOIDOSCOPE?

The FDA product code for FLEXIBLE IMMERSIBLE SIGMOIDOSCOPE is FAM.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Schott Fiber Optics, 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.

K892390FLEXIBLE IMMERSIBLE HYSTEROSCOPE

Related Devices (Code: FAM)

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.

K964131ENDOSCOPEAkos Biomedical, Inc.K970382VS-100 VIDEO SIGMOIDOSCOPEWelch Allyn, Inc.K964326VISION-SCIENCES MODEL S-V200 COLOR MVIDEO FLEXIBLE SIGMOIDOSCOPE WITH ENDOSHEATH SYSTEMVision-Sciences, Inc.K964100VISION-SCIENCES MODEL SS-U32 ENDO SHEATH FOR USE WITH THE VSI S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPE AND VSI S-V100Vision-Sciences, Inc.K963344DISPOSABLE SS-F32 ENDOSHEATH FOR USE WITH THE S-F100 FLEXIBLE FIBEROPTIC SIGMOIDOSCOPEVision-Sciences, Inc.K961567ES-3840, VIDEO SIGMOIDOSCOPEPentax Precision Instrument Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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