510(k) · Cleared
Recalled · Class II · 2018Fetzer Medical Gynecological Forceps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fetzer Medical GmbH & Co. KG · HCZ Forceps, Surgical, Gynecological
Cleared on May 8, 2018 as substantially equivalent to K134047 (Integra LifeSciences Corporation, 2014) after a 245-day review. Its family tree reaches back 2 generations to 2009. It has been recalled 4 times.
- Decided
- May 8, 2018
- Review
- 245 days
- Class
- Class II
- Product code
- HCZ
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 2 generations to K092840 (2009). No later device cites it as a predicate yet.
- Root · 2 generations backK092840 Instrumed Forceps Obstetrical/GynaecologicalInstrumed International, Inc. · 2009
- 1 generation backK134047 Jarit Gynecological Forceps, Miltex Gynecological Forceps…Integra LifeSciences Corporation · 2014
- This deviceK172661 Fetzer Medical Gynecological ForcepsFetzer Medical GmbH & Co. KG · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K092840 | Instrumed Forceps Obstetrical/Gynaecological | Instrumed International, Inc. | 2009 | — |
| −1 | K134047 | Jarit Gynecological Forceps, Miltex Gynecological Forceps, Meisterhand… | Integra LifeSciences Corporation | 2014 | — |
| 0 (this device) | K172661 | Fetzer Medical Gynecological Forceps | Fetzer Medical GmbH & Co. KG | 2018 | — |
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? (1)
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 |
|---|---|---|---|
| * | K134047 | Jarit Gynecological Forceps, Miltex Gynecological Forceps, Meisterhand Gynecoloical…Summary page 4…Instrument Product Code: HCZ (Forceps, Surgical, Gynecological) Regulatory Class: II 4. Predicate Device: Integra ® Gynecological Forceps (K134047) manufactured by Integra Lifesciences Corporation. The predicate device has not been subject to any design related recalls. 5. D… | 2014 |
| † | K160104 | Unnamed device | |
| † | K150468 | Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs | 2016 |
| † | K120492 | K2 Medical Vascular Clamps | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 28, 2018 | Class II | Z-0756-2019 | Device Design | The firm had a report of doctors being unable to pull the obstetric forceps apart. |
| Dec 28, 2018 | Class II | Z-0755-2019 | Device Design | The firm had a report of doctors being unable to pull the obstetric forceps apart. |
| Dec 28, 2018 | Class II | Z-0757-2019 | Device Design | The firm had a report of doctors being unable to pull the obstetric forceps apart. |
| Dec 28, 2018 | Class II | Z-0758-2019 | Device Design | The firm had a report of doctors being unable to pull the obstetric forceps apart. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All HCZ devicesHCZ Forceps, Surgical, Gynecological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
Fetzer Medical Gynecological 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/K172661 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172661: Fetzer Medical Gynecological Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172661
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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