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FDA 510(k)

UROTEK RE-USABLE FIBEROPTIC CABLE

K-Number: K951933 · 1995-05-26

ApplicantEnergy Life Systems Corp.
Decision Date1995-05-26
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

UROTEK RE-USABLE FIBEROPTIC CABLE is the device name listed in this FDA 510(k) record. The listed applicant is Energy Life Systems Corp.. It received FDA 510(k) clearance on 1995-05-26 under 510(k) number K951933. 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 UROTEK RE-USABLE FIBEROPTIC CABLE?

UROTEK RE-USABLE FIBEROPTIC CABLE is a medical device that received FDA 510(k) clearance on 1995-05-26. The listed applicant is Energy Life Systems Corp.. The 510(k) number is K951933.

When did UROTEK RE-USABLE FIBEROPTIC CABLE receive FDA 510(k) clearance?

UROTEK RE-USABLE FIBEROPTIC CABLE received FDA 510(k) clearance on 1995-05-26, under 510(k) number K951933.

Who is the listed applicant for UROTEK RE-USABLE FIBEROPTIC CABLE?

The FDA 510(k) record lists Energy Life Systems Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UROTEK RE-USABLE FIBEROPTIC CABLE?

The FDA product code for UROTEK RE-USABLE FIBEROPTIC CABLE is GEX. This falls under the Gastroenterology category.

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Other records listing Energy Life Systems Corp. 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.

K945560UROTEK LASER CATHETERK945563CONVERTIBLE CONTACT SIDE-FIRING REFRACTIVE FIBER (C-SRF(TM))K943409SIDE-FIRING UROLOGIC REFRACTIVE FIBERK934389UROTEK LASER CATHETER

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.

K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.K252723Dynamis Pro FamilyFotona D.O.O.K241973SmartIPL_NI SystemLumenis Be, Ltd.K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.

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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