FDA 510(k)

SIGMOSCOPE

K-Number: K771815 · 1977-10-07

Decision Date1977-10-07

Product CodeFAM

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

SIGMOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Dynatech Cryomedical Co.. It received FDA 510(k) clearance on 1977-10-07 under 510(k) number K771815. 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 SIGMOSCOPE?

SIGMOSCOPE is a medical device that received FDA 510(k) clearance on 1977-10-07. The listed applicant is Dynatech Cryomedical Co.. The 510(k) number is K771815.

When did SIGMOSCOPE receive FDA 510(k) clearance?

SIGMOSCOPE received FDA 510(k) clearance on 1977-10-07, under 510(k) number K771815.

Who is the listed applicant for SIGMOSCOPE?

The FDA 510(k) record lists Dynatech Cryomedical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIGMOSCOPE?

The FDA product code for SIGMOSCOPE 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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Dynatech Cryomedical Co. as applicant

K771898AUTOMATED SLIDE SPINNER K770896COLPOSCOPE MODEL II K770614MONITOR, GAS MANIFOLD K761205DYNATECH JD7/JD7P COLPOSCOPE K760763COLPOSCOPE (DYNATECH COLPOSCOPE-MODEL I

Related Devices (Code: FAM)

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.