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FDA 510(k)

AKRO-SIL PLUS

K-Number: K864736 · 1986-12-24

ApplicantAkron Catheter, Inc.
Decision Date1986-12-24
Product CodeKOD
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

AKRO-SIL PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Akron Catheter, Inc.. It received FDA 510(k) clearance on 1986-12-24 under 510(k) number K864736. 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 AKRO-SIL PLUS?

AKRO-SIL PLUS is a medical device that received FDA 510(k) clearance on 1986-12-24. The listed applicant is Akron Catheter, Inc.. The 510(k) number is K864736.

When did AKRO-SIL PLUS receive FDA 510(k) clearance?

AKRO-SIL PLUS received FDA 510(k) clearance on 1986-12-24, under 510(k) number K864736.

Who is the listed applicant for AKRO-SIL PLUS?

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

What is the FDA product code for AKRO-SIL PLUS?

The FDA product code for AKRO-SIL PLUS is KOD.

Other records listing Akron Catheter, 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.

K823428KELLY INFLATABLE T DRAINK760440CATHETER, NATURAL LATEX URETHRAL

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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