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FDA 510(k)

HGM, INC. LASERCATH (STERILE)

K-Number: K860357 · 1986-04-07

ApplicantHgm, Inc.
Decision Date1986-04-07
Product CodeLNK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

HGM, INC. LASERCATH (STERILE) is the device name listed in this FDA 510(k) record. The listed applicant is Hgm, Inc.. It received FDA 510(k) clearance on 1986-04-07 under 510(k) number K860357. The device is classified under product code LNK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HGM, INC. LASERCATH (STERILE)?

HGM, INC. LASERCATH (STERILE) is a medical device that received FDA 510(k) clearance on 1986-04-07. The listed applicant is Hgm, Inc.. The 510(k) number is K860357.

When did HGM, INC. LASERCATH (STERILE) receive FDA 510(k) clearance?

HGM, INC. LASERCATH (STERILE) received FDA 510(k) clearance on 1986-04-07, under 510(k) number K860357.

Who is the listed applicant for HGM, INC. LASERCATH (STERILE)?

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 HGM, INC. LASERCATH (STERILE)?

The FDA product code for HGM, INC. LASERCATH (STERILE) is LNK.

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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: LNK)

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.

K925395TECHNOMED PULSOLITH 4000 LASER SYSTEMTeknomed, Inc.K901723MDL-2000 LASERTRIPTERCandela Laser Corp.K874255ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI.Minnesota Laser Corp.K874253ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA.Minnesota Laser Corp.K880256MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USESharplan Lasers, Inc.K880193MODEL 4060 N ND:YAG LASER FOR UROLOGICAL USESharplan Lasers, 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.

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