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FDA 510(k)

CONTROLLED DISTENTION IRRIGATION SYSTEM CDIS 200

K-Number: K900908 · 1990-05-21

ApplicantZimmer, Inc.
Decision Date1990-05-21
Product CodeHIG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CONTROLLED DISTENTION IRRIGATION SYSTEM CDIS 200 is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 1990-05-21 under 510(k) number K900908. The device is classified under product code HIG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONTROLLED DISTENTION IRRIGATION SYSTEM CDIS 200?

CONTROLLED DISTENTION IRRIGATION SYSTEM CDIS 200 is a medical device that received FDA 510(k) clearance on 1990-05-21. The listed applicant is Zimmer, Inc.. The 510(k) number is K900908.

When did CONTROLLED DISTENTION IRRIGATION SYSTEM CDIS 200 receive FDA 510(k) clearance?

CONTROLLED DISTENTION IRRIGATION SYSTEM CDIS 200 received FDA 510(k) clearance on 1990-05-21, under 510(k) number K900908.

Who is the listed applicant for CONTROLLED DISTENTION IRRIGATION SYSTEM CDIS 200?

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

What is the FDA product code for CONTROLLED DISTENTION IRRIGATION SYSTEM CDIS 200?

The FDA product code for CONTROLLED DISTENTION IRRIGATION SYSTEM CDIS 200 is HIG.

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Related Devices (Code: HIG)

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.

K261706Endomat Select (UP220)KARL STORZ SE & CO. KGK251273Asurys Fluid Management SystemBoston Scientific CorporationK240886Fluent Pro Fluid Management System (FLT-200); Fluent Pro Fluid Management System Disposable Procedure Kit (6-pack) (FLT-212); Fluent Pro Fluid Management System Disposable Procedure Kit (1-pack) (FLT-212S); Fluent Pro Fluid Management System Tissue Trap Multipack (10-pack) (FLT-210); Fluent Pro Fluid Management System Waste Bag Multipack (5-pack) (FLT-205)Hologic, Inc.K210628X-FLO Fluid Management SystemThermedx, LLCK201355Endomat Select, IBS Shaver Software, LicenseKarl Storz SE & CO. KGK180735Endomat SelectKarl Storz SE & CO. KG

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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