# K021224: Endocervical Block Needle

- Pathway: 510(k) (Traditional)
- Applicant: Wallach Surgical Devices, Inc.
- Decided: Jul 12, 2002 after 86 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: 2 generations back to K771203 (1977). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 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 2.
- K000117: Avid-Nit Cervical Regional Anesthesia Needle, Avid Medical, Inc. (2000)
- K012646: Terumo 30 Gauge Hypodermic Needle, Terumo Medical Corp. (2001)
- K013293: Nipro Hypodermic Needle, Nipro Medical Corp. (2001)

## Most influential descendants
- K052365: Cervineedle Disposable Cartridge Syringe (2005), 0 descendants of its own

## Indications for use
This needle is designed for injection of solutions (such as 2% lidocaine with or without 1: 100,000 epinephrine) into the cervix. The application includes local anesthetics such as electro-excision, electro-fulguration, C02 laser excision, and vaporization, and when required, endocervical curettage and cervical biopsies.

Source page: https://510kreport.com/device/K021224
Methodology: https://510kreport.com/methodology