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FDA 510(k)

DEVINE (SUPRAPUBIC SOUND AND GUIDE)

K-Number: K873177 · 1987-10-14

ApplicantPenn Medical Devices, Inc.
Decision Date1987-10-14
Product CodeKOE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DEVINE (SUPRAPUBIC SOUND AND GUIDE) 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 1987-10-14 under 510(k) number K873177. The device is classified under product code KOE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEVINE (SUPRAPUBIC SOUND AND GUIDE)?

DEVINE (SUPRAPUBIC SOUND AND GUIDE) is a medical device that received FDA 510(k) clearance on 1987-10-14. The listed applicant is Penn Medical Devices, Inc.. The 510(k) number is K873177.

When did DEVINE (SUPRAPUBIC SOUND AND GUIDE) receive FDA 510(k) clearance?

DEVINE (SUPRAPUBIC SOUND AND GUIDE) received FDA 510(k) clearance on 1987-10-14, under 510(k) number K873177.

Who is the listed applicant for DEVINE (SUPRAPUBIC SOUND AND GUIDE)?

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 DEVINE (SUPRAPUBIC SOUND AND GUIDE)?

The FDA product code for DEVINE (SUPRAPUBIC SOUND AND GUIDE) is KOE.

Related Clinical Trials

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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 AIRWAYK873176HUFFMAN BIOPSY UNITK873178URETERAL BULB DILATORSK871667URETERAL STENTK870508GASTROINTESTINAL TUBEK862729PENN 3-RING HANDLE

View all 8 devices →

Related Devices (Code: KOE)

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.

K191061Optilume Basic Urological Balloon Dilation CatheterUrotronic, Inc.K032840ATRION MEDICAL QL INFLATION DEVICEAtrion Medical Products, Inc.K972964ATRION MEDICAL BALLOON CATHETER INFLATION DEVICEAtrion Medical Products, Inc.K962611BARD EAGLE INFLATION DEVICERyder Intl. Corp.K961904AQ HYDROPHILIC DILATORSCook Urological, Inc.K924440U.S. MEDICAL PS-7000 DIALYSIS SCALEU.S. Medical Corp.

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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