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FDA 510(k)

STRYKER INFRAVISION ESOPHAGEAL KIT

K-Number: K983220 · 1999-06-04

ApplicantStryker Endoscopy
Decision Date1999-06-04
Product CodeFAT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

STRYKER INFRAVISION ESOPHAGEAL KIT is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Endoscopy. It received FDA 510(k) clearance on 1999-06-04 under 510(k) number K983220. The device is classified under product code FAT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STRYKER INFRAVISION ESOPHAGEAL KIT?

STRYKER INFRAVISION ESOPHAGEAL KIT is a medical device that received FDA 510(k) clearance on 1999-06-04. The listed applicant is Stryker Endoscopy. The 510(k) number is K983220.

When did STRYKER INFRAVISION ESOPHAGEAL KIT receive FDA 510(k) clearance?

STRYKER INFRAVISION ESOPHAGEAL KIT received FDA 510(k) clearance on 1999-06-04, under 510(k) number K983220.

Who is the listed applicant for STRYKER INFRAVISION ESOPHAGEAL KIT?

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

What is the FDA product code for STRYKER INFRAVISION ESOPHAGEAL KIT?

The FDA product code for STRYKER INFRAVISION ESOPHAGEAL KIT is FAT.

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Related Devices (Code: FAT)

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.

K972119MALONEY BOUGE (1210-XX)/HURST BOUGIE (1212-XX)Medovations, Inc.K960173INFRA VISION BOUGIE KIT, INFRA VISION ESOPHAGEAL KITGabriel Medical, Inc.K901425PYLORIC BALLOON DILATORTelemed Systems, Inc.K843186ESKA MULTISTAGE ESOPHAGEAL BOUGIEDacomed Corp.K842679ESOPHAGEAL DILATOR SETMill-Rose LaboratoryK780471GASTRIC LAVAGE KITGaymar Industries, 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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