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FDA 510(k)

CONVERTIBLE CONTACT SIDE-FIRING REFRACTIVE FIBER (C-SRF(TM))

K-Number: K945563 · 1994-12-15

ApplicantEnergy Life Systems Corp.
Decision Date1994-12-15
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CONVERTIBLE CONTACT SIDE-FIRING REFRACTIVE FIBER (C-SRF(TM)) 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 1994-12-15 under 510(k) number K945563. 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 CONVERTIBLE CONTACT SIDE-FIRING REFRACTIVE FIBER (C-SRF(TM))?

CONVERTIBLE CONTACT SIDE-FIRING REFRACTIVE FIBER (C-SRF(TM)) is a medical device that received FDA 510(k) clearance on 1994-12-15. The listed applicant is Energy Life Systems Corp.. The 510(k) number is K945563.

When did CONVERTIBLE CONTACT SIDE-FIRING REFRACTIVE FIBER (C-SRF(TM)) receive FDA 510(k) clearance?

CONVERTIBLE CONTACT SIDE-FIRING REFRACTIVE FIBER (C-SRF(TM)) received FDA 510(k) clearance on 1994-12-15, under 510(k) number K945563.

Who is the listed applicant for CONVERTIBLE CONTACT SIDE-FIRING REFRACTIVE FIBER (C-SRF(TM))?

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 CONVERTIBLE CONTACT SIDE-FIRING REFRACTIVE FIBER (C-SRF(TM))?

The FDA product code for CONVERTIBLE CONTACT SIDE-FIRING REFRACTIVE FIBER (C-SRF(TM)) is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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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.

K951933UROTEK RE-USABLE FIBEROPTIC CABLEK945560UROTEK LASER CATHETERK943409SIDE-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.

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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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