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FDA 510(k)

VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLE

K-Number: K121370 · 2013-08-02

ApplicantVectec
Decision Date2013-08-02
Product CodeFHO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Vectec. It received FDA 510(k) clearance on 2013-08-02 under 510(k) number K121370. The device is classified under product code FHO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLE?

VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLE is a medical device that received FDA 510(k) clearance on 2013-08-02. The listed applicant is Vectec. The 510(k) number is K121370.

When did VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLE receive FDA 510(k) clearance?

VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLE received FDA 510(k) clearance on 2013-08-02, under 510(k) number K121370.

Who is the listed applicant for VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLE?

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

What is the FDA product code for VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLE?

The FDA product code for VECTEC DISPOSABLE PNEUMOPERITONEUM NEEDLE is FHO.

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 Vectec 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.

K103707VECTEC DISPOSABLE MONOPOLAR CONNECTOR CABLEK071976VECTEC DISPOSABLE TROCARS AND LAPAROSCOPIC ACCESSORIES

Related Devices (Code: FHO)

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.

K172120Veress NeedleWickimed (Huizhou) Medical Equipment Manufacturing Co.,LtdK010779MODIFICATION TO:LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTGibbons Surgical Corp.K970788PNEUMO-MATIC INSUFFLATION NEEDLEApple Medical Corp.K960574ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEMSherwood Medical Co.K951894ACCESS EXPANSION SYSTEMMicro-Medical Devices, Inc.K943624ELMED PNEUMOPERITONEUM NEEDLESHenke-Sass, Wolf 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.

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