510(k) · Cleared
ClearedInstrumed Forceps Obstetrical/Gynaecological
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumed International, Inc. · HCZ Forceps, Surgical, Gynecological
Cleared on Dec 3, 2009 after a 79-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.
- Decided
- Dec 3, 2009
- Review
- 79 days
- Class
- Class II
- Product code
- HCZ
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 1 citing it directly.
- This deviceK092840 Instrumed Forceps Obstetrical/GynaecologicalInstrumed International, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK134047 Jarit Gynecological Forceps, Miltex Gynecological Forceps…Integra LifeSciences Corporation · 2014
- Descendant · 2 generations on · 0 of its ownK172661 Fetzer Medical Gynecological ForcepsFetzer Medical GmbH & Co. KG · 2018 · Recalled
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 |
|---|---|---|---|---|---|
| 0 (this device) | K092840 | Instrumed Forceps Obstetrical/Gynaecological | Instrumed International, Inc. | 2009 | — |
| +1 | K134047 | Jarit Gynecological Forceps, Miltex Gynecological Forceps, Meisterhand… | Integra LifeSciences Corporation | 2014 | — |
| +2 | K172661 | Fetzer Medical Gynecological Forceps | Fetzer Medical GmbH & Co. KG | 2018 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 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 HCZ? 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? (7)
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 |
|---|---|---|---|
| * | — | Multiple Forceps, Surgical, Gynecological Named without a submission number | |
| * | — | Mader Surgical Forceps Named without a submission number | |
| * | — | Meisterhand Surgical Forceps Named without a submission number | |
| * | — | Miltex Surgical Forceps Named without a submission number | |
| * | — | Multiple Surgical Forceps Named without a submission number | |
| * | — | Sparta Surgical Forceps Named without a submission number | |
| * | — | Vantage Surgical Forceps Named without a submission number |
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 |
|---|---|---|---|
| K134047 | Jarit Gynecological Forceps, Miltex Gynecological Forceps, Meisterhand Gynecoloical… | 2014 | 1 |
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, K134047 (Integra LifeSciences Corporation, 2014) has gone furthest, with 1 descendant of its own.
How does its category compare?
All HCZ devicesHCZ Forceps, Surgical, Gynecological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · HCZ
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · HCZ
Too few HCZ 510(k)s in any year since 2007 to give a median.
Recalls per year · HCZ
No recall names HCZ since 2007.
Adverse event reports per year · HCZ
3in 2024
MAUDE reports naming product code HCZ, 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 | 3 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 1 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 1 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
INSTRUMED gynaecological forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynaecological examination.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092840 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092840: Instrumed Forceps Obstetrical/Gynaecological.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092840
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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