Cleared Traditional

K052365 - CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE

K052365 is an FDA 510(k) clearance for CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE, manufactured by Rocket Medical Plc. The device is a Class 2 Obstetrics & Gynecology device with product code HEE cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K052365 · Rocket Medical Plc · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2005
Decision
49d
Days
Class 2
Risk

K052365 is an FDA 510(k) clearance for the CERVINEEDLE DISPOSABLE CARTRIDGE SYRINGE. Classified as Set, Anesthesia, Paracervical (product code HEE), Class II - Special Controls.

Submitted by Rocket Medical Plc (Tyne & Wear, GB). The FDA issued a Cleared decision on October 17, 2005 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5100 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Rocket Medical Plc devices

FDA 510(k) Submission Details - K052365

510(k) Number K052365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2005
Decision Date October 17, 2005
Days to Decision 49 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 161d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HEE Device Classification - Class 2, Special Controls

Product Code HEE Set, Anesthesia, Paracervical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5100
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - HEE Set, Anesthesia, Paracervical

All 8
Devices cleared under the same product code (HEE) and FDA review panel - the closest regulatory comparables to K052365.
ENDOCERVICAL BLOCK NEEDLE
K021224 · Wallach Surgical Devices, Inc. · Jul 2002
AVID-NIT CERVICAL REGIONAL ANESTHESIA NEEDLE
K000117 · Avid Medical, Inc. · Apr 2000
CERVICAL ANESTHESIA NEEDLE, CONTRACERVICAL ANESTHESIA NEEDLE, MODEL #'S 720209 30GAU X 4 MM, 720210 30GAU X 6MM, 720208G
K983897 · Ri Mos. S.R.L. · Feb 1999
GYNEX EXTENDED REACH NEEDLE
K980238 · Gynex Corp. · Aug 1998
ENDOCERVICAL BLOCK NEEDLE
K973671 · A & A Medical, Inc. · Nov 1997
ELLMAN NEEDLE EXTENDER/MEASURED DOSE SYRINGE
K954718 · Ellman Intl., Inc. · Feb 1996