FDA 510(k)

MAYFIELD* A-2000 SKULL CLAMP

K-Number: K932807 · 1993-09-28

ApplicantOhio Medical Instrument Co., Inc.

Decision Date1993-09-28

Product CodeHBL

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

MAYFIELD* A-2000 SKULL CLAMP is the device name listed in this FDA 510(k) record. The listed applicant is Ohio Medical Instrument Co., Inc.. It received FDA 510(k) clearance on 1993-09-28 under 510(k) number K932807. The device is classified under product code HBL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAYFIELD* A-2000 SKULL CLAMP?

MAYFIELD* A-2000 SKULL CLAMP is a medical device that received FDA 510(k) clearance on 1993-09-28. The listed applicant is Ohio Medical Instrument Co., Inc.. The 510(k) number is K932807.

When did MAYFIELD* A-2000 SKULL CLAMP receive FDA 510(k) clearance?

MAYFIELD* A-2000 SKULL CLAMP received FDA 510(k) clearance on 1993-09-28, under 510(k) number K932807.

Who is the listed applicant for MAYFIELD* A-2000 SKULL CLAMP?

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

What is the FDA product code for MAYFIELD* A-2000 SKULL CLAMP?

The FDA product code for MAYFIELD* A-2000 SKULL CLAMP is HBL.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Ohio Medical Instrument Co., Inc. as applicant

K021604MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020 K013428MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM K992843THE MAYFIELD / ACCISS SYSTEM WITH WINDOWS NT FOR CRANIAL SURGERY, THE MAYFIELD / OPTICAL ACCISS SYSTEM WITH WINDOWS NT F K991267SPINE APPLICATIONS FOR THE MAYFIELD/ACCISS OPERATING ARM AND OPTICAL ACCISS SYSTEMS MODULE, MAYFIELD/ACCISS SPINE RING A K983282OMI OCCIPITAL CERVICAL LOOP, MODEL A1089 K982244MAYFIELD ACCISS OPTICAL SYSTEM

View all 19 devices →

Related Devices (Code: HBL)

K250423mb-FIX Cranial Stabilization SystemsMedical Bees GmbH K241883DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO Sterile Disposable Skull Pins Stainless Steel, Pediatric (36 pcs) (3006-10); DORO Sterile Disposable Skull Pin Titanium, Adult (36 pcs) (3006-20); DORO Sterile Disposable Skull Pin Titanium, Pediatric (36 pcs) (3006-30); DORO Sterile Disposable Skull Pin Stainless Steel, Adult (36 pcs) (3006-50)Pro Med Instruments GmbH K240319DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)Pro Med Instruments GmbH K203505DORO QR3 Headrest System (Aluminum)Pro Med Instruments GmbH K193438DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)Pro Med Instruments GmbH K191740DORO LUCENT® iXI and iMRI Headrest SystemPro Med Instruments GmbH

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.