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)

HOLE PUNCH

K-Number: K915824 · 1993-01-29

ApplicantAmerican Biomaterials Corp.
Decision Date1993-01-29
Product CodeFOZ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

HOLE PUNCH is the device name listed in this FDA 510(k) record. The listed applicant is American Biomaterials Corp.. It received FDA 510(k) clearance on 1993-01-29 under 510(k) number K915824. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOLE PUNCH?

HOLE PUNCH is a medical device that received FDA 510(k) clearance on 1993-01-29. The listed applicant is American Biomaterials Corp.. The 510(k) number is K915824.

When did HOLE PUNCH receive FDA 510(k) clearance?

HOLE PUNCH received FDA 510(k) clearance on 1993-01-29, under 510(k) number K915824.

Who is the listed applicant for HOLE PUNCH?

The FDA 510(k) record lists American Biomaterials Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HOLE PUNCH?

The FDA product code for HOLE PUNCH is FOZ.

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 American Biomaterials Corp. 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.

K922455EVERT-O-CATH CATHETERK924725AMERICAN BIOMED, INC. MICROSURGICAL INSTRUMENTSK880371BIOGLASS DENTAL ENDOSSEOUS RIDGE MAINTAINERK863796CREATIVE CARE SYSTEMS' IV START KITK843461BIOGLASS OSSICULAR RECONSTRUCTION PROSTH

Related Devices (Code: FOZ)

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.

K260432Ruby Intravascular CatheterVenocare, Inc.K260165Unimpregnated Central Venous CatheterSpectrum VascularK261041ClearSafe Closed SystemMedSource Labs, LLCK260539MedSource QuickSafe™ Safety IV Catheter; MedSource PurSafe™ Safety IV CatheterMedSource Labs, LLCK253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc.K252137BD Insyte™ IV CatheterBecton Dickinson Infusion Therapy Systems, 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.

↑