510(k) · Cleared
ClearedEndocervical Block Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
A & A Medical, Inc. · HEE Set, Anesthesia, Paracervical
Cleared on Nov 26, 1997 after a 61-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Nov 26, 1997
- Review
- 61 days
- Class
- Class II
- Product code
- HEE
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK973671 Endocervical Block NeedleA & A Medical, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK052365 Cervineedle Disposable Cartridge SyringeRocket Medical Plc · 2005
Most influential descendants
Showing 1 of 1 · See all- K052365Cervineedle Disposable Cartridge SyringeRocket Medical Plc · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K973671 | Endocervical Block Needle | A & A Medical, Inc. | 1997 | — |
| +1 | K052365 | Cervineedle Disposable Cartridge Syringe | Rocket Medical Plc | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HEE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Potocky Needle Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052365 | Cervineedle Disposable Cartridge Syringe | 2005 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K052365 (Rocket Medical Plc, 2005) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HEE devicesHEE Set, Anesthesia, Paracervical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HEE
FDA has decided no HEE device since 2007.
Median 510(k) review, days · HEE
Too few HEE 510(k)s in any year since 2007 to give a median.
Recalls per year · HEE
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HEE
3in 2022
MAUDE reports naming product code HEE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 1 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 5 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973671 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973671: Endocervical Block Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973671
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026