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FDA 510(k)

PLP LAPAROSCOPIC CHOLECYSTECTOMY SET

K-Number: K910137 · 1991-04-08

ApplicantPrecision Laser Products, Inc.
Decision Date1991-04-08
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PLP LAPAROSCOPIC CHOLECYSTECTOMY SET is the device name listed in this FDA 510(k) record. The listed applicant is Precision Laser Products, Inc.. It received FDA 510(k) clearance on 1991-04-08 under 510(k) number K910137. 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 PLP LAPAROSCOPIC CHOLECYSTECTOMY SET?

PLP LAPAROSCOPIC CHOLECYSTECTOMY SET is a medical device that received FDA 510(k) clearance on 1991-04-08. The listed applicant is Precision Laser Products, Inc.. The 510(k) number is K910137.

When did PLP LAPAROSCOPIC CHOLECYSTECTOMY SET receive FDA 510(k) clearance?

PLP LAPAROSCOPIC CHOLECYSTECTOMY SET received FDA 510(k) clearance on 1991-04-08, under 510(k) number K910137.

Who is the listed applicant for PLP LAPAROSCOPIC CHOLECYSTECTOMY SET?

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

What is the FDA product code for PLP LAPAROSCOPIC CHOLECYSTECTOMY SET?

The FDA product code for PLP LAPAROSCOPIC CHOLECYSTECTOMY SET is GEX. This falls under the Gastroenterology category.

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Other records listing Precision Laser Products, 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.

K912853PLP EVACUATION CONTROL SYSTEM 1 MICRO (ECS.1UM)K910985SINGLE-USE LAPAROSCOPIC SUCTION/IRRIGATION CANNULAK910184PLP LAPAROSCOPIC CHOLECYSTECTOMY DIS. ELEC. PROBES

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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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