FDA 510(k)

CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223

K-Number: K071931 · 2007-10-22

Decision Date2007-10-22

Product CodeHBF

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223 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 2007-10-22 under 510(k) number K071931. The device is classified under product code HBF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223?

CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223 is a medical device that received FDA 510(k) clearance on 2007-10-22. The listed applicant is Codman & Shurtleff, Inc.. The 510(k) number is K071931.

When did CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223 receive FDA 510(k) clearance?

CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223 received FDA 510(k) clearance on 2007-10-22, under 510(k) number K071931.

Who is the listed applicant for CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223?

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 PERFORATOR, MODEL(S) 26-1222, 26-1223?

The FDA product code for CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223 is HBF.

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: HBF)

K254177Disposable Sterile Skull Drill (LZ)Guizhou Zirui Technology Co., Ltd.K231403evoDrill Cranial PerforatorEvonos GmbH & Co. KG K213228NeuroLine Disposable Cranial Perforator with Hudson endEmd Endoszkop Muszer Gyarto ES Kereskedelmi Kft.K183581Codman Disposable PerforatorsIntegra Lifesciences Corp.K121253MERIDIAN CRANIAL PERFORATORAdeor Medical Technologies GmbH K082010STRYKER DISPOSABLE CRANIAL PERFORATOR BITStryker Ireland Ltd., Instruments Division

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.