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FDA 510(k)

DIOMED 25 SURGICAL DIODE LASER, GEN SURG APPLICAT

K-Number: K914521 · 1993-01-15

ApplicantDio-Med Corp.
Decision Date1993-01-15
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

DIOMED 25 SURGICAL DIODE LASER, GEN SURG APPLICAT is the device name listed in this FDA 510(k) record. The listed applicant is Dio-Med Corp.. It received FDA 510(k) clearance on 1993-01-15 under 510(k) number K914521. 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 DIOMED 25 SURGICAL DIODE LASER, GEN SURG APPLICAT?

DIOMED 25 SURGICAL DIODE LASER, GEN SURG APPLICAT is a medical device that received FDA 510(k) clearance on 1993-01-15. The listed applicant is Dio-Med Corp.. The 510(k) number is K914521.

When did DIOMED 25 SURGICAL DIODE LASER, GEN SURG APPLICAT receive FDA 510(k) clearance?

DIOMED 25 SURGICAL DIODE LASER, GEN SURG APPLICAT received FDA 510(k) clearance on 1993-01-15, under 510(k) number K914521.

Who is the listed applicant for DIOMED 25 SURGICAL DIODE LASER, GEN SURG APPLICAT?

The FDA 510(k) record lists Dio-Med Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIOMED 25 SURGICAL DIODE LASER, GEN SURG APPLICAT?

The FDA product code for DIOMED 25 SURGICAL DIODE LASER, GEN SURG APPLICAT is GEX. This falls under the Gastroenterology category.

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Other records listing Dio-Med 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.

K933525DIOMED 25 25W SURGICAL DIODE LASERK931776DIOMED 25 25W SURGICAL DIODE LASERK931212DIOMED 25 25W SURGICAL DIODE LASERK914519DIOMED 25 SURGICAL DIODE LASER, GYNECOLOGY APPLICK914520DIOMED 25 SURGICAL DIODE LASER, UROLOGY APPLICATK813267DISPOSABLE DIAPHRAGM DOMES

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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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