510(k) · Cleared
ClearedCampion Cervical Hook
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Simpson/Basye, Inc. · HDC Tenaculum, Uterine
Cleared on Mar 29, 1989 after a 19-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Mar 29, 1989
- Review
- 19 days
- Class
- Class II
- Product code
- HDC
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK891349 Campion Cervical HookSimpson/Basye, Inc. · 1989
- Descendant · cites it directly · 3 of its ownK980247 Gynex Iris Hook, Gynex Angle Hook, Gynex Emmett TenaculumGynex Corp. · 1998
- Descendant · 2 generations on · 2 of its ownK073182 Gyn Disposables Tenaculum 356TGyn-Disposables, Inc. · 2007 · Recalled
- Descendant · 3 generations on · 1 of its ownK203820 ASPIVIX v1.1 Cervical Suction TenaculumAspivix SA · 2021
- Descendant · 4 generations on · 0 of its ownK223866 Carevix™ Suction Cervical StabilizerAspivix SA · 2023
Most influential descendants
Showing 4 of 4 · See all- K980247Gynex Iris Hook, Gynex Angle Hook, Gynex Emmett TenaculumGynex Corp. · 1998 · cites it directly3descendants
- K073182Gyn Disposables Tenaculum 356TGyn-Disposables, Inc. · 2007 · 2 generations on2descendants
- K203820ASPIVIX v1.1 Cervical Suction TenaculumAspivix SA · 2021 · 3 generations on1descendant
- K223866Carevix™ Suction Cervical StabilizerAspivix SA · 2023 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K891349 | Campion Cervical Hook | Simpson/Basye, Inc. | 1989 | — |
| +1 | K980247 | Gynex Iris Hook, Gynex Angle Hook, Gynex Emmett Tenaculum | Gynex Corp. | 1998 | — |
| +2 | K073182 | Gyn Disposables Tenaculum 356T | Gyn-Disposables, Inc. | 2007 | 7 |
| +3 | K203820 | ASPIVIX v1.1 Cervical Suction Tenaculum | Aspivix SA | 2021 | — |
| +4 | K223866 | Carevix™ Suction Cervical Stabilizer | Aspivix SA | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2007 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K980247 | Gynex Iris Hook, Gynex Angle Hook, Gynex Emmett Tenaculum | 1998 | 3 |
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, K980247 (Gynex Corp., 1998) has gone furthest, with 3 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 | — |
https://510kreport.com/device/K891349 · printed Nov 4, 2026
Cite this page
510(k) Report. “K891349: Campion Cervical Hook.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K891349
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026