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FDA 510(k)

KOI DIAMOND KNIFE

K-Number: K812450 · 1981-09-21

ApplicantKoi, Inc.
Decision Date1981-09-21
Product CodeHNN
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

KOI DIAMOND KNIFE is the device name listed in this FDA 510(k) record. The listed applicant is Koi, Inc.. It received FDA 510(k) clearance on 1981-09-21 under 510(k) number K812450. The device is classified under product code HNN. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KOI DIAMOND KNIFE?

KOI DIAMOND KNIFE is a medical device that received FDA 510(k) clearance on 1981-09-21. The listed applicant is Koi, Inc.. The 510(k) number is K812450.

When did KOI DIAMOND KNIFE receive FDA 510(k) clearance?

KOI DIAMOND KNIFE received FDA 510(k) clearance on 1981-09-21, under 510(k) number K812450.

Who is the listed applicant for KOI DIAMOND KNIFE?

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

What is the FDA product code for KOI DIAMOND KNIFE?

The FDA product code for KOI DIAMOND KNIFE is HNN.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Koi, 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.

K843247KOI PACHYMETERK830366DIAMOND KNIFEK812764KOI BLUE FIELD ENTOPTOSCOPEK812097KOI LACREMAL HOOK & DILATORK812010KOI LACRIMAL INTUBATION SYSTEMK812011BLADE GAUGE

View all 7 devices →

Related Devices (Code: HNN)

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.

K110166CLEARCUT S SAFETY KNIFEAlcon Research, Ltd.K922378OPHTHALMIC KNIFEMicroptics Development LaboratoryK882402RETRACTIVE INCISION MICROMETER (RIM) GUAGEOptical CenterK881669MVR/STILETTO BLADE 20GA. - P/N 1900Advanced Surgical Products, Inc.K874979PRISMA DISPOSABLE MVR/STILETTO BLADEAdvanced Surgical Products, Inc.K874057OPHTHALMIC TIP & BLADE SCALPELSMyocure, 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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