# K973671: Endocervical Block Needle

- Pathway: 510(k) (Traditional)
- Applicant: A & A Medical, Inc.
- Decided: Nov 26, 1997 after 61 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Potocky Needle: named in the summary without a submission number

## 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% fidocaine with or without . 1:100,000 epinephrine) into the cervix. Local anesthetics such as electroexcision, electrofuiguration, CO2 laser excision and vaporization, and in some patients, endocervical curettage and cemvical biopsies

Source page: https://510kreport.com/device/K973671
Methodology: https://510kreport.com/methodology
