# K052365: Cervineedle Disposable Cartridge Syringe

- Pathway: 510(k) (Traditional)
- Applicant: Rocket Medical Plc
- Decided: Oct 17, 2005 after 49 days
- Product code: HEE (Set, Anesthesia, Paracervical)
- Device class: 2
- Regulation: 21 CFR 884.5100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K771203 (1977). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910252: Potocky Neddle (TM) Disposable Injection Needle, CooperSurgical, Inc. (1991) Summary page 1.
- K021224: Endocervical Block Needle, Wallach Surgical Devices, Inc. (2002) Summary page 1.
- K973671: Endocervical Block Needle, A & A Medical, Inc. (1997) Summary page 1.

## Indications for use
For injection of solutions (such as lidocaine with or without 1:100,000 eninephine) into the cervix. The application includes procedures that require local anaesthetics such as loop electro excision procedure (LEEP), elecro-fulguration, C02 laser excision and vaporization, and when required, endocervical curettage and cervical biopsies. For use with 2.2ml glass vials, such as those containing local anaesthetic agents.

Source page: https://510kreport.com/device/K052365
Methodology: https://510kreport.com/methodology