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FDA 510(k)

PERCUDISC PLDD DELIVERY SYSTEM/PROCEDURE KIT

K-Number: K920673 · 1992-08-13

ApplicantPercudisc, Inc.
Decision Date1992-08-13
Product CodeGEX
Advisory CommitteeSU
DecisionUnknown

Device Summary

PERCUDISC PLDD DELIVERY SYSTEM/PROCEDURE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Percudisc, Inc.. It received FDA 510(k) clearance on 1992-08-13 under 510(k) number K920673. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Unknown.

Frequently Asked Questions

What is the PERCUDISC PLDD DELIVERY SYSTEM/PROCEDURE KIT?

PERCUDISC PLDD DELIVERY SYSTEM/PROCEDURE KIT is a medical device that received FDA 510(k) clearance on 1992-08-13. The listed applicant is Percudisc, Inc.. The 510(k) number is K920673.

When did PERCUDISC PLDD DELIVERY SYSTEM/PROCEDURE KIT receive FDA 510(k) clearance?

PERCUDISC PLDD DELIVERY SYSTEM/PROCEDURE KIT received FDA 510(k) clearance on 1992-08-13, under 510(k) number K920673.

Who is the listed applicant for PERCUDISC PLDD DELIVERY SYSTEM/PROCEDURE KIT?

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

What is the FDA product code for PERCUDISC PLDD DELIVERY SYSTEM/PROCEDURE KIT?

The FDA product code for PERCUDISC PLDD DELIVERY SYSTEM/PROCEDURE KIT is GEX. This falls under the Gastroenterology category.

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Other records listing Percudisc, 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.

K910823PERCUDISC(TM) SYSTEM

Related Devices (Code: GEX)

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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Official Source

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