510(k) · Cleared
ClearedGynex Iris Hook, Gynex Angle Hook, Gynex Emmett Tenaculum
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gynex Corp. · HDC Tenaculum, Uterine
Cleared on Mar 17, 1998 as substantially equivalent to K890379 (Kinetic Medical Products, 1989) and 2 other predicates after a 53-day review. Its family tree reaches back 1 generation to 1989. 3 later devices descend from it.
- Decided
- Mar 17, 1998
- Review
- 53 days
- Class
- Class II
- Product code
- HDC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K890379 (1989). 3 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK890379 Uterine TentaculumKinetic Medical Products · 1989
- This deviceK980247 Gynex Iris Hook, Gynex Angle Hook, Gynex Emmett TenaculumGynex Corp. · 1998
- Descendant · cites it directly · 2 of its ownK073182 Gyn Disposables Tenaculum 356TGyn-Disposables, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 1 of its ownK203820 ASPIVIX v1.1 Cervical Suction TenaculumAspivix SA · 2021
- Descendant · 3 generations on · 0 of its ownK223866 Carevix™ Suction Cervical StabilizerAspivix SA · 2023
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K890379 | Uterine Tentaculum | Kinetic Medical Products | 1989 | — |
| 0 (this device) | K980247 | Gynex Iris Hook, Gynex Angle Hook, Gynex Emmett Tenaculum | Gynex Corp. | 1998 | — |
| +1 | K073182 | Gyn Disposables Tenaculum 356T | Gyn-Disposables, Inc. | 2007 | 7 |
| +2 | K203820 | ASPIVIX v1.1 Cervical Suction Tenaculum | Aspivix SA | 2021 | — |
| +3 | K223866 | Carevix™ Suction Cervical Stabilizer | Aspivix SA | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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 HDC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HDC device
- #1 K223866 Carevix™ Suction Cervical Stabilizerscore 5.6 · 4 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K890379 | Uterine TentaculumSummary page 2…5HDC 4. Preamendments Device: 1. Emmett Tenaculum Hooks, V. Mueller, The Surgical Armamentarium, 1973. 5. Equivalent Legally Marketed Device(s): 1. UterineTenaculum, K890379 - Mfg. by Kenetic Medical Products, Inc. 2. Champion Cervical Hook, K891349 - Mfg. by Simpson/Basye, Inc. 3. Zinnanti Atraumatic… | 1989 |
| * | K891349 | Campion Cervical HookSummary page 2…urgical Armamentarium, 1973. 5. Equivalent Legally Marketed Device(s): 1. UterineTenaculum, K890379 - Mfg. by Kenetic Medical Products, Inc. 2. Champion Cervical Hook, K891349 - Mfg. by Simpson/Basye, Inc. 3. Zinnanti Atraumatic Tenacula, K890133 - Mfg. by Zinnanti Surgical, Inc. 6. Device Description:… | 1989 |
| * | K891033 | Atraumatic Tenacula Our OCR of the scanned summary read K890133, FDA’s number for Ocular Connection Machine (TM) (Innovision Medical, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Zinnanti Atraumatic Tenacula”. | 1989 |
| * | — | Emmett Tenaculum Hooks, V. Mueller Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073182 | Gyn Disposables Tenaculum 356T | 2007 | 2 |
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?
- None of the 3 ancestors has a recall.
- Of its descendants, K073182 (Gyn-Disposables, Inc., 2007) has gone furthest, with 2 descendants of its own.
How does its category compare?
All HDC devicesHDC Tenaculum, Uterine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HDC
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · HDC
Too few HDC 510(k)s in any year since 2007 to give a median.
Recalls per year · HDC
6in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HDC
5in 2022
MAUDE reports naming product code HDC, 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 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 1 | 2 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 1 | — | 1 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 1 | — | 6 | 4 |
| 2022 | 0 | — | 0 | 5 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
GYNEX Tenaculum - Grasp/manipulate the cervix & soft tissue
GYNEX Iris Hook - Grasp/manipulate cervical tissue
GYNEX Angle Hook - Grasp/manipulate cervical tissue
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/K980247 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980247: Gynex Iris Hook, Gynex Angle Hook, Gynex Emmett Tenaculum.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980247
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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