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)

BIOPSY PUNCH, SURGICAL

K-Number: K933670 · 1994-01-07

ApplicantByron Medical
Decision Date1994-01-07
Product CodeEME
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BIOPSY PUNCH, SURGICAL is the device name listed in this FDA 510(k) record. The listed applicant is Byron Medical. It received FDA 510(k) clearance on 1994-01-07 under 510(k) number K933670. The device is classified under product code EME. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOPSY PUNCH, SURGICAL?

BIOPSY PUNCH, SURGICAL is a medical device that received FDA 510(k) clearance on 1994-01-07. The listed applicant is Byron Medical. The 510(k) number is K933670.

When did BIOPSY PUNCH, SURGICAL receive FDA 510(k) clearance?

BIOPSY PUNCH, SURGICAL received FDA 510(k) clearance on 1994-01-07, under 510(k) number K933670.

Who is the listed applicant for BIOPSY PUNCH, SURGICAL?

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

What is the FDA product code for BIOPSY PUNCH, SURGICAL?

The FDA product code for BIOPSY PUNCH, SURGICAL is EME.

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 Byron Medical 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.

K040149PSI-TEC PERISTALTIC INFILTRATION PUMPK001803ACCELERATOR RECIPROCATING CANNULAK981215PSI-TEC LIPOSUCTION ASPIRATORK981172LIPOPLASTY/ LIPOSUCTION ASPIRATION AND TUMESCENT INFUSION CANNULAE AND NEEDLESK980738PSI-TEC SYRINGE INFUSION PUMP AND ACCESSORIES FOR GENERAL FLUID IRRIGAION/INFILTRATIONK980392PSI-TEC ASPIRATOR

View all 27 devices →

Related Devices (Code: EME)

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.

K911285PULPDENT POLYAMIDE DENTIN LINERPulpdent Corp.K884740EURO-MED LIGHT TOUCH BIOPSY PUNCHBuckman Co., 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.

↑