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FDA 510(k)

PENN & OLYMPUS URETEROSCOPY GUIDE SHEATH & DILATOR

K-Number: K862107 · 1986-09-11

ApplicantPenn Medical Devices, Inc.
Decision Date1986-09-11
Product CodeODC
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

PENN & OLYMPUS URETEROSCOPY GUIDE SHEATH & DILATOR 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 1986-09-11 under 510(k) number K862107. The device is classified under product code ODC. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PENN & OLYMPUS URETEROSCOPY GUIDE SHEATH & DILATOR?

PENN & OLYMPUS URETEROSCOPY GUIDE SHEATH & DILATOR is a medical device that received FDA 510(k) clearance on 1986-09-11. The listed applicant is Penn Medical Devices, Inc.. The 510(k) number is K862107.

When did PENN & OLYMPUS URETEROSCOPY GUIDE SHEATH & DILATOR receive FDA 510(k) clearance?

PENN & OLYMPUS URETEROSCOPY GUIDE SHEATH & DILATOR received FDA 510(k) clearance on 1986-09-11, under 510(k) number K862107.

Who is the listed applicant for PENN & OLYMPUS URETEROSCOPY GUIDE SHEATH & DILATOR?

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 PENN & OLYMPUS URETEROSCOPY GUIDE SHEATH & DILATOR?

The FDA product code for PENN & OLYMPUS URETEROSCOPY GUIDE SHEATH & DILATOR is ODC.

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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 UNITK873178URETERAL BULB DILATORSK871667URETERAL STENTK870508GASTROINTESTINAL TUBE

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Related Devices (Code: ODC)

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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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