510(k) · Cleared
ClearedJarit Gynecological Forceps, Miltex Gynecological Forceps, Meisterhand Gynecoloical Forceps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra LifeSciences Corporation · HCZ Forceps, Surgical, Gynecological
Cleared on Apr 11, 2014 as substantially equivalent to K092840 (Instrumed International, Inc., 2009) after a 101-day review. Its family tree reaches back 1 generation to 2009. 1 later device descends from it.
- Decided
- Apr 11, 2014
- Review
- 101 days
- Class
- Class II
- Product code
- HCZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K092840 (2009). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK092840 Instrumed Forceps Obstetrical/GynaecologicalInstrumed International, Inc. · 2009
- This deviceK134047 Jarit Gynecological Forceps, Miltex Gynecological Forceps…Integra LifeSciences Corporation · 2014
- Descendant · cites it directly · 0 of its ownK172661 Fetzer Medical Gynecological ForcepsFetzer Medical GmbH & Co. KG · 2018 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K172661Fetzer Medical Gynecological ForcepsFetzer Medical GmbH & Co. KG · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K092840 | Instrumed Forceps Obstetrical/Gynaecological | Instrumed International, Inc. | 2009 | — |
| 0 (this device) | K134047 | Jarit Gynecological Forceps, Miltex Gynecological Forceps, Meisterhand… | Integra LifeSciences Corporation | 2014 | — |
| +1 | K172661 | Fetzer Medical Gynecological Forceps | Fetzer Medical GmbH & Co. KG | 2018 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K092840 | Instrumed Forceps Obstetrical/GynaecologicalSummary page 2…Manufacturer Preamendment Miltex®9 Gynecological Forceps E. Miltenberg, Inc. K092840 Forceps Obstetrical/Gynaccological Instrumed International, Inc. Preamendment_… | 2009 |
| * | — | Miltex® Gynecological Forceps Named without a submission number | |
| * | — | Miniclamps, Stabiliz, Fallopian Tube Named without a submission number | |
| † | K971977 | Ksea 15.5 FR. Flexible Choledocho-Fiberscope | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172661 | Fetzer Medical Gynecological Forceps | 2018 | 0 |
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.
- Of its descendants, K172661 (Fetzer Medical GmbH & Co. KG, 2018) has gone furthest, with 0 descendants 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. 2014, 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?
Integra® Gynecological Surgical Forceps are hand-held instruments with dual blades that are indicated for pulling, grasping, holding, or compressing tissue during gynecological procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K134047 · printed Nov 4, 2026
Cite this page
510(k) Report. “K134047: Jarit Gynecological Forceps, Miltex Gynecological Forceps, Meisterhand Gynecoloical Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K134047
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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