Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BLADE GAUGE

K-Number: K812011 · 1981-07-28

ApplicantKoi, Inc.
Decision Date1981-07-28
Product CodeHOE
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

BLADE GAUGE is the device name listed in this FDA 510(k) record. The listed applicant is Koi, Inc.. It received FDA 510(k) clearance on 1981-07-28 under 510(k) number K812011. The device is classified under product code HOE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLADE GAUGE?

BLADE GAUGE is a medical device that received FDA 510(k) clearance on 1981-07-28. The listed applicant is Koi, Inc.. The 510(k) number is K812011.

When did BLADE GAUGE receive FDA 510(k) clearance?

BLADE GAUGE received FDA 510(k) clearance on 1981-07-28, under 510(k) number K812011.

Who is the listed applicant for BLADE GAUGE?

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 BLADE GAUGE?

The FDA product code for BLADE GAUGE is HOE.

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 ENTOPTOSCOPEK812450KOI DIAMOND KNIFEK812097KOI LACREMAL HOOK & DILATORK812010KOI LACRIMAL INTUBATION SYSTEM

View all 7 devices →

Related Devices (Code: HOE)

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.

K881094KOI(TM) BLADE GAUGE, MODEL KOI-132CooperVision, Inc.K813315CALIPER-OPTHALMICDesign Research Assoc., Inc.K820050KREMER BLADE GAUGEAccutome, Inc.K801937BLEPHAROMETERAztec Medical Products, Inc.K792383KELMAN DIPSTICKV. Mueller O.V. Baxter Healthcare Corp.K781715RULER, WECK SCOTTEdward Weck, 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.

↑