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FDA 510(k)

COSGROVE MITRAL VALVE RETRACTOR

K-Number: K844177 · 1984-11-08

ApplicantKapp Surgical Instrument, Inc.
Decision Date1984-11-08
Product CodeGAD
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COSGROVE MITRAL VALVE RETRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is Kapp Surgical Instrument, Inc.. It received FDA 510(k) clearance on 1984-11-08 under 510(k) number K844177. The device is classified under product code GAD. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COSGROVE MITRAL VALVE RETRACTOR?

COSGROVE MITRAL VALVE RETRACTOR is a medical device that received FDA 510(k) clearance on 1984-11-08. The listed applicant is Kapp Surgical Instrument, Inc.. The 510(k) number is K844177.

When did COSGROVE MITRAL VALVE RETRACTOR receive FDA 510(k) clearance?

COSGROVE MITRAL VALVE RETRACTOR received FDA 510(k) clearance on 1984-11-08, under 510(k) number K844177.

Who is the listed applicant for COSGROVE MITRAL VALVE RETRACTOR?

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

What is the FDA product code for COSGROVE MITRAL VALVE RETRACTOR?

The FDA product code for COSGROVE MITRAL VALVE RETRACTOR is GAD.

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 Kapp Surgical Instrument, 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.

K200289Michler-Kapp Cardiovascular Vent CatheterK072216KAPP BARI-RING ENDOSCOPIC MARKER, MODEL K-9536K050384KAPP BARI-RING, MODEL KS-BR-2005K050655MONDEAL RADIUS HO SYSTEM, MODEL KS-MR-2005K050657MONDEAL CONTOUR HO SYSTEMK033930KAPP CUSTOM ULNAR HEAD WRIST IMPLANT

View all 9 devices →

Related Devices (Code: GAD)

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.

K152538JRP Wound SpreaderJ.R. Parker, LLCK151104OTELO LLSpineartK132645THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADESMedtronic, Inc.K071775DASHEzsurgicalK050256APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTORApple Medical Corp.K043602QUADRANT RETRACTOR SYSTEMMedtronic Sofamor Danek

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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