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)

MICRO-TORQUE HAND ENGINE & ACCESS. DERMABRA. BURS

K-Number: K873475 · 1987-09-11

ApplicantMcghan Medical Corp.
Decision Date1987-09-11
Product CodeGEY
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MICRO-TORQUE HAND ENGINE & ACCESS. DERMABRA. BURS is the device name listed in this FDA 510(k) record. The listed applicant is Mcghan Medical Corp.. It received FDA 510(k) clearance on 1987-09-11 under 510(k) number K873475. The device is classified under product code GEY. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICRO-TORQUE HAND ENGINE & ACCESS. DERMABRA. BURS?

MICRO-TORQUE HAND ENGINE & ACCESS. DERMABRA. BURS is a medical device that received FDA 510(k) clearance on 1987-09-11. The listed applicant is Mcghan Medical Corp.. The 510(k) number is K873475.

When did MICRO-TORQUE HAND ENGINE & ACCESS. DERMABRA. BURS receive FDA 510(k) clearance?

MICRO-TORQUE HAND ENGINE & ACCESS. DERMABRA. BURS received FDA 510(k) clearance on 1987-09-11, under 510(k) number K873475.

Who is the listed applicant for MICRO-TORQUE HAND ENGINE & ACCESS. DERMABRA. BURS?

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

What is the FDA product code for MICRO-TORQUE HAND ENGINE & ACCESS. DERMABRA. BURS?

The FDA product code for MICRO-TORQUE HAND ENGINE & ACCESS. DERMABRA. BURS is GEY.

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 Mcghan Medical 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.

K873476MINI-MOTOR HAND ENGINE & ACCESS. DERMABRASION BURSK870754MCGHAN TISSUE EXPANDER FILL SYSTEMK864185MCGHAN LONGTERM MAMMARY EXPANDER, RTV DESIGNK864184MCGHAN LONGTERM MAMMARY EXPANDER/GEL-SALINE DESIGNK862203MCGHAN MAGNA-SITE(TM) TISSUE EXPANDERK854794MCGHAN INTEGRAL VALVE TISSUE EXPANDER

View all 14 devices →

Related Devices (Code: GEY)

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.

K050519ADVANCED TURBO DRIVE SYSTEMLinvatec Corp.K020621ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDSArthrocare Corp.K012738SYMPHONY GRAFT DELIVERY SYSTEM (GDS)DepuyacromedK972308MEDNEXT 1000 DRILLMednext, Inc.K971941AQUA SPRAYBoyd Industries, Inc.K971782BONE AND MARROW COLLECTION SYSTEM KITBiomedical Ent., 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.

↑