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FDA 510(k)

GLASSMAN SILICONE CATHETER

K-Number: K934895 · 1994-10-13

ApplicantAxiom Medical, Inc.
Decision Date1994-10-13
Product CodeEZL
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

GLASSMAN SILICONE CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Axiom Medical, Inc.. It received FDA 510(k) clearance on 1994-10-13 under 510(k) number K934895. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLASSMAN SILICONE CATHETER?

GLASSMAN SILICONE CATHETER is a medical device that received FDA 510(k) clearance on 1994-10-13. The listed applicant is Axiom Medical, Inc.. The 510(k) number is K934895.

When did GLASSMAN SILICONE CATHETER receive FDA 510(k) clearance?

GLASSMAN SILICONE CATHETER received FDA 510(k) clearance on 1994-10-13, under 510(k) number K934895.

Who is the listed applicant for GLASSMAN SILICONE CATHETER?

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

What is the FDA product code for GLASSMAN SILICONE CATHETER?

The FDA product code for GLASSMAN SILICONE CATHETER is EZL.

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Other records listing Axiom Medical, 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.

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Related Devices (Code: EZL)

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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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