FDA 510(k)

SLT LASER CONTINUOUS FLOW TESECTOSCOPE (CFR)

K-Number: K936038 · 1994-05-27

ApplicantSurgical Laser Technologies, Inc.

Decision Date1994-05-27

Product CodeFJL

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

SLT LASER CONTINUOUS FLOW TESECTOSCOPE (CFR) is the device name listed in this FDA 510(k) record. The listed applicant is Surgical Laser Technologies, Inc.. It received FDA 510(k) clearance on 1994-05-27 under 510(k) number K936038. The device is classified under product code FJL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SLT LASER CONTINUOUS FLOW TESECTOSCOPE (CFR)?

SLT LASER CONTINUOUS FLOW TESECTOSCOPE (CFR) is a medical device that received FDA 510(k) clearance on 1994-05-27. The listed applicant is Surgical Laser Technologies, Inc.. The 510(k) number is K936038.

When did SLT LASER CONTINUOUS FLOW TESECTOSCOPE (CFR) receive FDA 510(k) clearance?

SLT LASER CONTINUOUS FLOW TESECTOSCOPE (CFR) received FDA 510(k) clearance on 1994-05-27, under 510(k) number K936038.

Who is the listed applicant for SLT LASER CONTINUOUS FLOW TESECTOSCOPE (CFR)?

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

What is the FDA product code for SLT LASER CONTINUOUS FLOW TESECTOSCOPE (CFR)?

The FDA product code for SLT LASER CONTINUOUS FLOW TESECTOSCOPE (CFR) is FJL.

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Other records listing Surgical Laser Technologies, Inc. as applicant

K042211MODIFICATION TO: LASERPRO 810, 940, AND 980 DIODE DIODE LASER SYSTEMS K023624SLT VENOUS FIBER DELIVERY SYSTEMS, MODEL: 0041-6772/0041-6781/0041-6752/0041-6761/0041-6912/0041-6921 K011409SLT LASERPRO CTH HOLMIUM LASER SYSTEM K010041SLT DIFFUSER FIBER K984018HEMOSLEEVE, MODEL 4.0MM, 5.5MM K983050PNEUMATIC CUTTER SYSTEM

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Related Devices (Code: FJL)

K232486KARL STORZ Monopolar Resectoscopes with HF CableKarl Storz SE & CO. KG K221893KARL STORZ Bipolar Resectoscopes with HF CableKarl Storz Endoscopy America, Inc.K230205Veloxion SystemCorinth Medtech, Inc.K191341Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management BagsCorinth Medtech, Inc.K190099Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue CatchCorinth Medtech, Inc.K162979Veloxion SystemCorinth Medtech, Inc.

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.