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FDA 510(k)

BURKE CONGENITAL THORACOSCOPY INSTRUMENTS

K-Number: K962771 · 1996-11-19

ApplicantPilling Weck, Inc.
Decision Date1996-11-19
Product CodeDWS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BURKE CONGENITAL THORACOSCOPY INSTRUMENTS is the device name listed in this FDA 510(k) record. The listed applicant is Pilling Weck, Inc.. It received FDA 510(k) clearance on 1996-11-19 under 510(k) number K962771. The device is classified under product code DWS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BURKE CONGENITAL THORACOSCOPY INSTRUMENTS?

BURKE CONGENITAL THORACOSCOPY INSTRUMENTS is a medical device that received FDA 510(k) clearance on 1996-11-19. The listed applicant is Pilling Weck, Inc.. The 510(k) number is K962771.

When did BURKE CONGENITAL THORACOSCOPY INSTRUMENTS receive FDA 510(k) clearance?

BURKE CONGENITAL THORACOSCOPY INSTRUMENTS received FDA 510(k) clearance on 1996-11-19, under 510(k) number K962771.

Who is the listed applicant for BURKE CONGENITAL THORACOSCOPY INSTRUMENTS?

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

What is the FDA product code for BURKE CONGENITAL THORACOSCOPY INSTRUMENTS?

The FDA product code for BURKE CONGENITAL THORACOSCOPY INSTRUMENTS is DWS.

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 Pilling Weck, 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.

K990547PILLING WECK SURGICAL Y STENT FORCEPSK974250VERSASTAT MULTIPOLAR SCISSORS AND CABLESK945520HEMOCLIP ECOSYSTEMK944552PILLING WECK M-20 DISPOSABLE AUTOMATIC HEMOCLIPK943719VISISTAT STAPLER

Related Devices (Code: DWS)

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.

K022238MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626Medtronic VascularK964445OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006)Dlp, Inc.K955689RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAYContour Fabricators of Florida, Inc.K960139G.E. STERILE ANGIOGRAPHIC TRAYGE Medical SystemsK960144G.E. STERILE CT BIOPSY TRAYGE Medical SystemsK960143G.E. STERILE DIGITAL ANGIOGRAPHIC TRAYGE Medical Systems

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.

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