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FDA 510(k)

MODEL 2100 ND:YAG SURGICAL LASER UROLOGICAL INDICA

K-Number: K861046 · 1986-05-02

ApplicantSharplan Industries, Inc.
Decision Date1986-05-02
Product CodeLNK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODEL 2100 ND:YAG SURGICAL LASER UROLOGICAL INDICA is the device name listed in this FDA 510(k) record. The listed applicant is Sharplan Industries, Inc.. It received FDA 510(k) clearance on 1986-05-02 under 510(k) number K861046. 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 MODEL 2100 ND:YAG SURGICAL LASER UROLOGICAL INDICA?

MODEL 2100 ND:YAG SURGICAL LASER UROLOGICAL INDICA is a medical device that received FDA 510(k) clearance on 1986-05-02. The listed applicant is Sharplan Industries, Inc.. The 510(k) number is K861046.

When did MODEL 2100 ND:YAG SURGICAL LASER UROLOGICAL INDICA receive FDA 510(k) clearance?

MODEL 2100 ND:YAG SURGICAL LASER UROLOGICAL INDICA received FDA 510(k) clearance on 1986-05-02, under 510(k) number K861046.

Who is the listed applicant for MODEL 2100 ND:YAG SURGICAL LASER UROLOGICAL INDICA?

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

What is the FDA product code for MODEL 2100 ND:YAG SURGICAL LASER UROLOGICAL INDICA?

The FDA product code for MODEL 2100 ND:YAG SURGICAL LASER UROLOGICAL INDICA is LNK.

Related Clinical Trials

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Other records listing Sharplan Industries, 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.

K861044MODEL 2100 ND:YAG SURGICAL LASER NEUROSURGICAL INDK861047MODEL 2100 ND:YAG SURGICAL LASER GASTROINTESTINALK861045MODEL 2100 ND:YAG SURGICAL LASER PULMONARY INDICAT

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

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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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