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FDA 510(k)

10-C/SA-10B/U OPT 20-C/20A/U BEAM SA-10B/U HEMORRH

K-Number: K871031 · 1987-05-15

ApplicantDirected Energy, Inc.
Decision Date1987-05-15
Product CodeLNK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

10-C/SA-10B/U OPT 20-C/20A/U BEAM SA-10B/U HEMORRH is the device name listed in this FDA 510(k) record. The listed applicant is Directed Energy, Inc.. It received FDA 510(k) clearance on 1987-05-15 under 510(k) number K871031. 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 10-C/SA-10B/U OPT 20-C/20A/U BEAM SA-10B/U HEMORRH?

10-C/SA-10B/U OPT 20-C/20A/U BEAM SA-10B/U HEMORRH is a medical device that received FDA 510(k) clearance on 1987-05-15. The listed applicant is Directed Energy, Inc.. The 510(k) number is K871031.

When did 10-C/SA-10B/U OPT 20-C/20A/U BEAM SA-10B/U HEMORRH receive FDA 510(k) clearance?

10-C/SA-10B/U OPT 20-C/20A/U BEAM SA-10B/U HEMORRH received FDA 510(k) clearance on 1987-05-15, under 510(k) number K871031.

Who is the listed applicant for 10-C/SA-10B/U OPT 20-C/20A/U BEAM SA-10B/U HEMORRH?

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

What is the FDA product code for 10-C/SA-10B/U OPT 20-C/20A/U BEAM SA-10B/U HEMORRH?

The FDA product code for 10-C/SA-10B/U OPT 20-C/20A/U BEAM SA-10B/U HEMORRH is LNK.

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Other records listing Directed Energy, Inc. as applicant

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K904930SURGICAL CARBON DIOXIDE LASER SYST MODEL 20-CHK894241MODEL 20-CH W/ AR-10A/U OPTICAL ATTACHMENTK883738CARBON DIOXIDE LASER SYSTEM MODEL 20-CX W/ATTACH.K882926MODEL AU-1 ACCESSORY UNITK880216MODEL 20C W/AN AR-10A/U & RL-20A/U FOR ARTHROSCOP.K873331ORTHO. GAS INSUFFLATOR MODEL IN-2 FOR ARTHRO. SURG

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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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