510(k) · Cleared
ClearedGynex Extended Reach Needle
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gynex Corp. · HEE Set, Anesthesia, Paracervical
Cleared on Aug 21, 1998 as substantially equivalent to K910252 (CooperSurgical, Inc., 1991) after a 210-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Aug 21, 1998
- Review
- 210 days
- Class
- Class II
- Product code
- HEE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K910252 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK910252 Potocky Neddle (TM) Disposable Injection NeedleCooperSurgical, Inc. · 1991
- This deviceK980238 Gynex Extended Reach NeedleGynex Corp. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910252 | Potocky Neddle (TM) Disposable Injection Needle | CooperSurgical, Inc. | 1991 | — |
| 0 (this device) | K980238 | Gynex Extended Reach Needle | Gynex Corp. | 1998 | — |
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 |
|---|---|---|---|
| * | K910252 | Potocky Neddle (TM) Disposable Injection NeedleSummary page 1…, Gynecology, Obstetrics, V. Mueller, The Surgical Armamentarium, 1973, pp. 219 Equivalent Legally Marketed Device(s): 1. Potocky Needle - Disposable Injection Needle, K910252, Cooper Surgical. GYNEX-EXTEND.doc 18 10. 11. 12 Device Description: K4&o13¢ r 293 The Gynex Extended Reach… | 1991 |
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?
- Its one ancestor has no recall.
- 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?
1. Injection and administration of anesthetic regional blocks
(e.g., paracervical, uterosacral, and pudendal) that may be
used during labor, delivery, or both.
2. Injection and administration of anesthetic regional blocks
(e.g., paracervical, uterosacral, and pudendal) that may be
used during minor surgical procedures.
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/K980238 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980238: Gynex Extended Reach Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980238
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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