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)

ACU-E PUNCH

K-Number: K933516 · 1994-03-24

ApplicantAcuderm, Inc.
Decision Date1994-03-24
Product CodeLRY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACU-E PUNCH is the device name listed in this FDA 510(k) record. The listed applicant is Acuderm, Inc.. It received FDA 510(k) clearance on 1994-03-24 under 510(k) number K933516. The device is classified under product code LRY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACU-E PUNCH?

ACU-E PUNCH is a medical device that received FDA 510(k) clearance on 1994-03-24. The listed applicant is Acuderm, Inc.. The 510(k) number is K933516.

When did ACU-E PUNCH receive FDA 510(k) clearance?

ACU-E PUNCH received FDA 510(k) clearance on 1994-03-24, under 510(k) number K933516.

Who is the listed applicant for ACU-E PUNCH?

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

What is the FDA product code for ACU-E PUNCH?

The FDA product code for ACU-E PUNCH is LRY.

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 Acuderm, 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.

K933265ACU-DISPO-CE(TM)K933137ACU-SUTURE KITK930043ACU-EVACK933866ACU-HEMOSTATIC RINGK915000ACU-GUARDK891334ACU-CURETTE

View all 13 devices →

Related Devices (Code: LRY)

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.

K904869ELLIPSE PUNCHKramer ConstK902636LIPOGEN RHEUMELISA DSDNA ASSAYLipogen, Inc.K896303BIOPSY PUNCHPremier MedicalK874356PIN PUNCHMed-Tool, Inc.K874357TAPERED PUNCHMed-Tool, Inc.K872388NAIL SETMed-Tool, 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.

↑