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FDA 510(k)

CONCEPT SUCTION COAGULATOR

K-Number: K800321 · 1980-02-28

ApplicantConcept, Inc.
Decision Date1980-02-28
Product CodeKNS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CONCEPT SUCTION COAGULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Concept, Inc.. It received FDA 510(k) clearance on 1980-02-28 under 510(k) number K800321. The device is classified under product code KNS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONCEPT SUCTION COAGULATOR?

CONCEPT SUCTION COAGULATOR is a medical device that received FDA 510(k) clearance on 1980-02-28. The listed applicant is Concept, Inc.. The 510(k) number is K800321.

When did CONCEPT SUCTION COAGULATOR receive FDA 510(k) clearance?

CONCEPT SUCTION COAGULATOR received FDA 510(k) clearance on 1980-02-28, under 510(k) number K800321.

Who is the listed applicant for CONCEPT SUCTION COAGULATOR?

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

What is the FDA product code for CONCEPT SUCTION COAGULATOR?

The FDA product code for CONCEPT SUCTION COAGULATOR is KNS.

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Other records listing Concept, 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.

K912640CONCEPT ENDOSTEAL FIXATION DEVICEK912957CONCEPT MICROMILLK896648CONCEPT UNICOMPARTMENTAL KNEE SYSTEMK894929STAPLE FIXATION SYSTEMK892376INTRAVISION(TM) ARTHROSCOPE SYSTEM (ADD'L APPLI.)K891109PANDA(R) NEEDLE CATHETER JEJUNOSTOMY TUBE

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Related Devices (Code: KNS)

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.

K262460Rezum SystemBoston ScientificK260962SphincterotomeTaewoong Medical Co., Ltd.K252388Vanquish Water Vapor Ablation DeviceFrancis Medical, Inc.K252889Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M)Olympus Medical Systems CorporationK250945Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series); Single Use Sphincterotome V (Distal Wire Guided) (KD-VC400 Series); Single Use 3-Lumen Sphincterotome (KD-V Series); Disposable Triple Lumen Sphincterotome (KD Series)Olympus Medical Systems Corp.K250351Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife (KD-620UR); Single Use Electrosurgical Knife (KD-650L, KD-650U)Olympus Medical Systems Corporation

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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