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FDA 510(k)

PEREGRINE STRAIGHT LASER PROBE, MODEL PD6000.00

K-Number: K024061 · 2003-03-07

ApplicantPeregrine Surgical , Ltd.
Decision Date2003-03-07
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PEREGRINE STRAIGHT LASER PROBE, MODEL PD6000.00 is the device name listed in this FDA 510(k) record. The listed applicant is Peregrine Surgical , Ltd.. It received FDA 510(k) clearance on 2003-03-07 under 510(k) number K024061. 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: Substantially Equivalent.

Frequently Asked Questions

What is the PEREGRINE STRAIGHT LASER PROBE, MODEL PD6000.00?

PEREGRINE STRAIGHT LASER PROBE, MODEL PD6000.00 is a medical device that received FDA 510(k) clearance on 2003-03-07. The listed applicant is Peregrine Surgical , Ltd.. The 510(k) number is K024061.

When did PEREGRINE STRAIGHT LASER PROBE, MODEL PD6000.00 receive FDA 510(k) clearance?

PEREGRINE STRAIGHT LASER PROBE, MODEL PD6000.00 received FDA 510(k) clearance on 2003-03-07, under 510(k) number K024061.

Who is the listed applicant for PEREGRINE STRAIGHT LASER PROBE, MODEL PD6000.00?

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

What is the FDA product code for PEREGRINE STRAIGHT LASER PROBE, MODEL PD6000.00?

The FDA product code for PEREGRINE STRAIGHT LASER PROBE, MODEL PD6000.00 is GEX. This falls under the Gastroenterology category.

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Other records listing Peregrine Surgical , Ltd. 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.

K132614PEREGRINE CURVED ILLUMINATING LASER PROBEK12299723GA CURVED ILLUMINATING LASER PROBEK122905PEREGRINE 23GA CURVED LASER PROBEK061024PEREGRINE SOFT TIP ASPIRATING LASER PROBE, MODEL PD720.60K031023PEREGRINE ILLUMINATING LASER PROBE MODEL PD600.10K990518PEREGRINE WET SET, MODEL PD400.00

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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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