510(k) · Cleared
ClearedCervineedle Disposable Cartridge Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rocket Medical Plc · HEE Set, Anesthesia, Paracervical
Cleared on Oct 17, 2005 as substantially equivalent to K910252 (CooperSurgical, Inc., 1991) and 2 other predicates after a 49-day review. Its family tree reaches back 3 generations to 1977.
- Decided
- Oct 17, 2005
- Review
- 49 days
- Class
- Class II
- Product code
- HEE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K771203 (1977). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK771203 Disp. Hypodermic NeedleTerumo America, Inc. · 1977 · Recalled
- 2 generations backK012646 Terumo 30 Gauge Hypodermic NeedleTerumo Medical Corp. · 2001
- 1 generation backK021224 Endocervical Block NeedleWallach Surgical Devices, Inc. · 2002
- This deviceK052365 Cervineedle Disposable Cartridge SyringeRocket Medical Plc · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K771203 | Disp. Hypodermic Needle | Terumo America, Inc. | 1977 | 1 |
| −2 | K012646 | Terumo 30 Gauge Hypodermic Needle | Terumo Medical Corp. | 2001 | — |
| −1 | K021224 | Endocervical Block Needle | Wallach Surgical Devices, Inc. | 2002 | — |
| 0 (this device) | K052365 | Cervineedle Disposable Cartridge Syringe | Rocket Medical Plc | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 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? (3)
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 |
|---|---|---|---|
| * | K910252 | Potocky Neddle (TM) Disposable Injection NeedleSummary page 1…ially equivalent to medical devices which are currently in commerce and have been submitted to the FDA. CooperSurgical Inc Potocky NeedleTM Disposable Injection Needle #K910252 Wallach Surgical Devices Inc, Endocervical Block Needle, #K021224 A & A Medical Inc, Endocervical Block Needle, #K973671 Based o… | 1991 |
| * | K021224 | Endocervical Block NeedleSummary page 1…e and have been submitted to the FDA. CooperSurgical Inc Potocky NeedleTM Disposable Injection Needle #K910252 Wallach Surgical Devices Inc, Endocervical Block Needle, #K021224 A & A Medical Inc, Endocervical Block Needle, #K973671 Based on the indications for use, technical characteristics and compariso… | 2002 |
| * | K973671 | Endocervical Block NeedleSummary page 1…nc Potocky NeedleTM Disposable Injection Needle #K910252 Wallach Surgical Devices Inc, Endocervical Block Needle, #K021224 A & A Medical Inc, Endocervical Block Needle, #K973671 Based on the indications for use, technical characteristics and comparison to currently commercial marketed devices, the Rocket… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 28 years and passes through 4 companies; a new generation was cleared every 3.3 years on median.
- 1 of the 8 ancestors has a recall of any class.
- 2 other devices also cite its predicate K910252.
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?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052365 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052365: Cervineedle Disposable Cartridge Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052365
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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