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FDA 510(k)

E-25 KRYPTON ION LASER (SURGICA K5)

K-Number: K930543 · 1993-06-22

ApplicantHgm, Inc.
Decision Date1993-06-22
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

E-25 KRYPTON ION LASER (SURGICA K5) is the device name listed in this FDA 510(k) record. The listed applicant is Hgm, Inc.. It received FDA 510(k) clearance on 1993-06-22 under 510(k) number K930543. 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 E-25 KRYPTON ION LASER (SURGICA K5)?

E-25 KRYPTON ION LASER (SURGICA K5) is a medical device that received FDA 510(k) clearance on 1993-06-22. The listed applicant is Hgm, Inc.. The 510(k) number is K930543.

When did E-25 KRYPTON ION LASER (SURGICA K5) receive FDA 510(k) clearance?

E-25 KRYPTON ION LASER (SURGICA K5) received FDA 510(k) clearance on 1993-06-22, under 510(k) number K930543.

Who is the listed applicant for E-25 KRYPTON ION LASER (SURGICA K5)?

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

What is the FDA product code for E-25 KRYPTON ION LASER (SURGICA K5)?

The FDA product code for E-25 KRYPTON ION LASER (SURGICA K5) is GEX. This falls under the Gastroenterology category.

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Other records listing Hgm, 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.

K950120SMART PLUGK931072HGM ILLUMINATING/ASPIRATING ENDOOCULAR PROBEK931784HGM ILLUMINATING IMAGING ENDOCULAR PROBEK933333HGM SCANMAN PLUSK931499Q-11 OPHTHALMIC LASERK925663HGM ASPIRATING ENDOOCULAR(TM) PROBE

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Related Devices (Code: GEX)

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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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