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FDA 510(k)

WATERS ILEAL RESERVOIR CATHETER

K-Number: K813494 · 1981-12-31

ApplicantWaters Instruments, Inc.
Decision Date1981-12-31
Product CodeKPH
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

WATERS ILEAL RESERVOIR CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Waters Instruments, Inc.. It received FDA 510(k) clearance on 1981-12-31 under 510(k) number K813494. The device is classified under product code KPH. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WATERS ILEAL RESERVOIR CATHETER?

WATERS ILEAL RESERVOIR CATHETER is a medical device that received FDA 510(k) clearance on 1981-12-31. The listed applicant is Waters Instruments, Inc.. The 510(k) number is K813494.

When did WATERS ILEAL RESERVOIR CATHETER receive FDA 510(k) clearance?

WATERS ILEAL RESERVOIR CATHETER received FDA 510(k) clearance on 1981-12-31, under 510(k) number K813494.

Who is the listed applicant for WATERS ILEAL RESERVOIR CATHETER?

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

What is the FDA product code for WATERS ILEAL RESERVOIR CATHETER?

The FDA product code for WATERS ILEAL RESERVOIR CATHETER is KPH.

Related Clinical Trials

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Other records listing Waters Instruments, 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.

K053169RM3 RENAL PRESERVATION SYSTEMK042224RM3 RENAL PRESERVATION SYSTEMK971571RM3 RENAL PRESERVATION SYSTEM--CONTROL UNITK921519OXICOM-2100K911207OXICOMPLUSK863210VELCOM-100

View all 12 devices →

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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