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FDA 510(k)

URETERAL BULB DILATORS

K-Number: K873178 · 1987-09-30

ApplicantPenn Medical Devices, Inc.
Decision Date1987-09-30
Product CodeEZN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

URETERAL BULB DILATORS is the device name listed in this FDA 510(k) record. The listed applicant is Penn Medical Devices, Inc.. It received FDA 510(k) clearance on 1987-09-30 under 510(k) number K873178. The device is classified under product code EZN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URETERAL BULB DILATORS?

URETERAL BULB DILATORS is a medical device that received FDA 510(k) clearance on 1987-09-30. The listed applicant is Penn Medical Devices, Inc.. The 510(k) number is K873178.

When did URETERAL BULB DILATORS receive FDA 510(k) clearance?

URETERAL BULB DILATORS received FDA 510(k) clearance on 1987-09-30, under 510(k) number K873178.

Who is the listed applicant for URETERAL BULB DILATORS?

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

What is the FDA product code for URETERAL BULB DILATORS?

The FDA product code for URETERAL BULB DILATORS is EZN.

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Other records listing Penn Medical Devices, 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.

K873949RORERTAZZI NASOPHARYNGEAL AIRWAYK873177DEVINE (SUPRAPUBIC SOUND AND GUIDE)K873176HUFFMAN BIOPSY UNITK871667URETERAL STENTK870508GASTROINTESTINAL TUBEK862729PENN 3-RING HANDLE

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Related Devices (Code: EZN)

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.

K250910Optilume® High Pressure Urological Balloon Dilation CatheterUrotronic, Inc.K220781ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer CatheterAllwin Medical Devices, Inc.K201007In-Ka Ureteral Balloon Dilatation CatheterColoplast Corp.K190612EQUINOX Balloon Dilatation CatheterDornier Medtech America, Inc.K173654Ureteral Dilator Sets, Ureteral DilatorsCook IncorporatedK180756Safety Wire Guide IntroducerCook Incorporated

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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