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FDA 510(k)

CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE

K-Number: K052365 · 2005-10-17

ApplicantRocket Medical Plc
Decision Date2005-10-17
Product CodeHEE
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Rocket Medical Plc. It received FDA 510(k) clearance on 2005-10-17 under 510(k) number K052365. The device is classified under product code HEE. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE?

CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE is a medical device that received FDA 510(k) clearance on 2005-10-17. The listed applicant is Rocket Medical Plc. The 510(k) number is K052365.

When did CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE receive FDA 510(k) clearance?

CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE received FDA 510(k) clearance on 2005-10-17, under 510(k) number K052365.

Who is the listed applicant for CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE?

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

What is the FDA product code for CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE?

The FDA product code for CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE is HEE.

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Other records listing Rocket Medical Plc 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.

K210509Rocket Platinum Cured CathterK163321Rocket Indwelling Pleural Catheter (IPC) Insertion KitK162457Rocket Indwelling Peritoneal Catheter (IPC) Insertion KitK152105Rocket IPC Insertion Set, Rocket IPC Mini Insertion SetK123033ROCKET IPC INSERTION PACK, ROCKET IPC MINI INSERTION SET, ROCKET IPC DRESSING PACK AND BOTTLE SET, ROCKET IPC DRAINAGE BK042264GUIDEWIRES

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Related Devices (Code: HEE)

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.

K021224ENDOCERVICAL BLOCK NEEDLEWallach Surgical Devices, Inc.K000117AVID-NIT CERVICAL REGIONAL ANESTHESIA NEEDLEAvid Medical, Inc.K983897CERVICAL ANESTHESIA NEEDLE, CONTRACERVICAL ANESTHESIA NEEDLE, MODEL #'S 720209 30GAU X 4 MM, 720210 30GAU X 6MM, 720208GRi Mos. S.R.L.K980238GYNEX EXTENDED REACH NEEDLEGynex Corp.K973671ENDOCERVICAL BLOCK NEEDLEA & A Medical, Inc.K954718ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGEEllman Intl., Inc.

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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