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FDA 510(k)

VS-100 VIDEO SIGMOIDOSCOPE

K-Number: K970382 · 1997-04-17

ApplicantWelch Allyn, Inc.
Decision Date1997-04-17
Product CodeFAM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VS-100 VIDEO SIGMOIDOSCOPE is the device name listed in this FDA 510(k) record. The listed applicant is Welch Allyn, Inc.. It received FDA 510(k) clearance on 1997-04-17 under 510(k) number K970382. 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 VS-100 VIDEO SIGMOIDOSCOPE?

VS-100 VIDEO SIGMOIDOSCOPE is a medical device that received FDA 510(k) clearance on 1997-04-17. The listed applicant is Welch Allyn, Inc.. The 510(k) number is K970382.

When did VS-100 VIDEO SIGMOIDOSCOPE receive FDA 510(k) clearance?

VS-100 VIDEO SIGMOIDOSCOPE received FDA 510(k) clearance on 1997-04-17, under 510(k) number K970382.

Who is the listed applicant for VS-100 VIDEO SIGMOIDOSCOPE?

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

What is the FDA product code for VS-100 VIDEO SIGMOIDOSCOPE?

The FDA product code for VS-100 VIDEO SIGMOIDOSCOPE is FAM.

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Other records listing Welch Allyn, 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.

K243598Welch Allyn Connex® 360 (Multiple)K241411Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)K223381iExaminer System with Panoptic PlusK212473Welch Allyn Connex Central StationK191013Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry optionK181016Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System

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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.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.K951577ES-3800, VIDEO SIGMOIDOSCOPEPentax Precision Instrument Corp.

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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