FDA 510(k)

CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KIT

K-Number: K853770 · 1986-10-06

Decision Date1986-10-06

Product CodeGWM

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KIT is the device name listed in this FDA 510(k) record. The listed applicant is Codman & Shurtleff, Inc.. It received FDA 510(k) clearance on 1986-10-06 under 510(k) number K853770. The device is classified under product code GWM. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KIT?

CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KIT is a medical device that received FDA 510(k) clearance on 1986-10-06. The listed applicant is Codman & Shurtleff, Inc.. The 510(k) number is K853770.

When did CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KIT receive FDA 510(k) clearance?

CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KIT received FDA 510(k) clearance on 1986-10-06, under 510(k) number K853770.

Who is the listed applicant for CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KIT?

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

What is the FDA product code for CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KIT?

The FDA product code for CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KIT is GWM.

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 Codman & Shurtleff, Inc. as applicant

K193380CERENOVUS Large Bore Catheter; CERENOVUS Aspiration Tubing Set K191237CERENOVUS Large Bore Catheter K173192CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit K172537Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag K172022CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)K171862GALAXY G3 Mini Microcoil Delivery System

View all 147 devices →

Related Devices (Code: GWM)

K252241Pressio 3 Multi-parameter Neuromonitoring SystemSophysa K250285NEUROVENT-P (092946-003); NEUROVENT (092956-003); NEUROVENT-IFD-R (095317-003); NEUROVENT-IFD-S (091678-003); NEUROVENT-P-TEMP (094268-003); NEUROVENT-TEMP (094278-003); NEUROVENT-TEMP-IFD-R (095327-003); NEUROVENT-TEMP-IFD-S (094288-003); NEUROVENT-PTO (095008-003); NEUROVENT-PTO 2L (095108-003); NEUROVENT-PX (091580-003); BOLT-DRILL KIT CH5 (091888-003); BOLT-DRILL KIT CH9 (091898-003); BOLT-DRILL KIT PTO (092380-003); BOLT-DRILL KIT VP 16 (092969-003); BOLT KIT CH5 (091868-003); BOLRaumedic AG K240821B4C System - Addition of new sensor model (BcSs-PICNIW-2000)Braincare Desenvolvimento E Inovação Tecnológica S.A.K232890CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)Integra Lifesciences Production Corporation K201989B4C SystemBraincare Desenvolvimento E Inovacao Tecnologica S.A.K210993CereLink ICP MonitorIntegra Lifesciences Production Corporation

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.