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FDA 510(k)

SYRINGE PREFILLED WITH WATER

K-Number: K881363 · 1988-06-23

ApplicantI M, Inc.
Decision Date1988-06-23
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SYRINGE PREFILLED WITH WATER is the device name listed in this FDA 510(k) record. The listed applicant is I M, Inc.. It received FDA 510(k) clearance on 1988-06-23 under 510(k) number K881363. The device is classified under product code KOD. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYRINGE PREFILLED WITH WATER?

SYRINGE PREFILLED WITH WATER is a medical device that received FDA 510(k) clearance on 1988-06-23. The listed applicant is I M, Inc.. The 510(k) number is K881363.

When did SYRINGE PREFILLED WITH WATER receive FDA 510(k) clearance?

SYRINGE PREFILLED WITH WATER received FDA 510(k) clearance on 1988-06-23, under 510(k) number K881363.

Who is the listed applicant for SYRINGE PREFILLED WITH WATER?

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

What is the FDA product code for SYRINGE PREFILLED WITH WATER?

The FDA product code for SYRINGE PREFILLED WITH WATER is KOD.

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Other records listing I M, 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.

K914600NEUROLOGICAL SPONGEK892389BIOPSY KITK880753UMBILICAL CORD CLAMPK872741NUTRIPUMPK871495BANDAGES CATALOG NUMBER: 101 TO 220K863785MAKLER CATHETER

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Related Devices (Code: KOD)

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.

K251864Rubber Utility CatheterC.R. Bard, Inc.K220036Wellead Ureteral CatheterWell Lead Medical Co., Ltd.K220730allFlex Ureteral Catheters, Krait Ureteral CathetersAllwin Medical Devices, Inc.K211032Urinary Catheter 12 Fr, Urinary Catheter 16 FrUrogen Pharma, Ltd.K181979Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent CatheterTeleflexmedical, Inc.K180354UroGen Ureteral CatheterUrogen Pharma, Ltd.

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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