510(k) · Cleared
Recalled · Class II · 2021Gyn Disposables Tenaculum 356T
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gyn-Disposables, Inc. · HDC Tenaculum, Uterine
Cleared on Nov 28, 2007 as substantially equivalent to K930037 (Thomasville Medical Assoc., 1994) and 1 other predicate after a 15-day review. Its family tree reaches back 2 generations to 1989. 2 later devices descend from it. It has been recalled 7 times.
- Decided
- Nov 28, 2007
- Review
- 15 days
- Class
- Class II
- Product code
- HDC
- Recalls
- 7
- Predicates
- 2
Its longest line of descent runs back 2 generations to K890379 (1989). 5 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK890379 Uterine TentaculumKinetic Medical Products · 1989
- 1 generation backK980247 Gynex Iris Hook, Gynex Angle Hook, Gynex Emmett TenaculumGynex Corp. · 1998
- This deviceK073182 Gyn Disposables Tenaculum 356TGyn-Disposables, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK203820 ASPIVIX v1.1 Cervical Suction TenaculumAspivix SA · 2021
- Descendant · 2 generations on · 0 of its ownK223866 Carevix™ Suction Cervical StabilizerAspivix SA · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K890379 | Uterine Tentaculum | Kinetic Medical Products | 1989 | — |
| −1 | K980247 | Gynex Iris Hook, Gynex Angle Hook, Gynex Emmett Tenaculum | Gynex Corp. | 1998 | — |
| 0 (this device) | K073182 | Gyn Disposables Tenaculum 356T | Gyn-Disposables, Inc. | 2007 | — |
| +1 | K203820 | ASPIVIX v1.1 Cervical Suction Tenaculum | Aspivix SA | 2021 | — |
| +2 | K223866 | Carevix™ Suction Cervical Stabilizer | Aspivix SA | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 2 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K930037 | Atraumatic TenaculaSummary page 2…The GYN Disposable Tenaculum is supplied in a Tyvek pouch and has been sterilized by gamma radiation. Substantial Equivalence: Atraumatic Tenacula (K930037) and Gynex Iris Hook, Gynex Angle Hook, Gynex Emmett Tenaculum (K980247) are predicate devices. GYN Dis… | 1994 |
| * | K980247 | Gynex Iris Hook, Gynex Angle Hook, Gynex Emmett TenaculumSummary page 2…zed by gamma radiation. Substantial Equivalence: Atraumatic Tenacula (K930037) and Gynex Iris Hook, Gynex Angle Hook, Gynex Emmett Tenaculum (K980247) are predicate devices. GYN Disposables Thomasville Medical Gynex Corp… | 1998 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203820 | ASPIVIX v1.1 Cervical Suction Tenaculum | 2021 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 10, 2021 | Class II | Z-0128-2022 | Device Design | Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards. |
| Sep 10, 2021 | Class II | Z-0126-2022 | Device Design | Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards. |
| Sep 10, 2021 | Class II | Z-0127-2022 | Device Design | Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards. |
| Sep 10, 2021 | Class II | Z-0129-2022 | Device Design | Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards. |
| Sep 10, 2021 | Class II | Z-0130-2022 | Device Design | Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards. |
| Sep 10, 2021 | Class II | Z-0131-2022 | Device Design | Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards. |
| Jul 29, 2011 | Not classified | Z-3025-2011 | Process design | Lack of sterility assurance. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 9.7 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K203820 (Aspivix SA, 2021) has gone furthest, with 1 descendant 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. 2007, this device’s year, is highlighted.
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?
Snare, grasp, hold and manipulate cervical and intravaginal tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073182 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073182: Gyn Disposables Tenaculum 356T.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073182
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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