510(k) · Cleared
ClearedGrasping Forceps, Biopsy Forceps, Spoon Forceps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KARL STORZ Endoscopy-America, Inc. · FCL Forceps, Biopsy, Non-Electric
Cleared on Jan 25, 1994 after a 92-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 later devices descend from it.
- Decided
- Jan 25, 1994
- Review
- 92 days
- Class
- Class I
- Product code
- FCL
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 1 citing it directly.
- This deviceK935070 Grasping Forceps, Biopsy Forceps, Spoon ForcepsKARL STORZ Endoscopy-America, Inc. · 1994
- Descendant · cites it directly · 11 of its ownK973648 Mini Forceps with HF, 3.5MM; Micro Forceps with HF, 2MMRichard Wolf Medical Instruments Corp. · 1997
- Descendant · 2 generations on · 10 of its ownK980758 3 MM Selec-Tip Laparoscopic ScissorsMicroline Pentax, Inc. · 1998
- Descendant · 3 generations on · 8 of its ownK014207 Reposable Instrument System, Models MF001-MF083Aesculap, Inc. · 2002
- Descendant · 4 generations on · 7 of its ownK063485 Logic Laparoscopic ScissorsSurgical Innovations Plc · 2006
- Descendant · 5 generations on · 4 of its ownK090583 Endoscopic Monopolar Scissors, Models Ems-235, Ems-165Apollo Endosurgery, Inc. · 2009
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K973648Mini Forceps with HF, 3.5MM; Micro Forceps with HF, 2MMRichard Wolf Medical Instruments Corp. · 1997 · cites it directly11descendants
- K9807583 MM Selec-Tip Laparoscopic ScissorsMicroline Pentax, Inc. · 1998 · 2 generations on10descendants
- K014207Reposable Instrument System, Models MF001-MF083Aesculap, Inc. · 2002 · 3 generations on8descendants
- K063485Logic Laparoscopic ScissorsSurgical Innovations Plc · 2006 · 4 generations on7descendants
- K090583Endoscopic Monopolar Scissors, Models Ems-235, Ems-165Apollo Endosurgery, Inc. · 2009 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K935070 | Grasping Forceps, Biopsy Forceps, Spoon Forceps | KARL STORZ Endoscopy-America, Inc. | 1994 | — |
| +1 | K973648 | Mini Forceps with HF, 3.5MM; Micro Forceps with HF, 2MM | Richard Wolf Medical Instruments Corp. | 1997 | — |
| +2 | K980758 | 3 MM Selec-Tip Laparoscopic Scissors | Microline Pentax, Inc. | 1998 | — |
| +3 | K014207 | Reposable Instrument System, Models MF001-MF083 | Aesculap, Inc. | 2002 | — |
| +4 | K063485 | Logic Laparoscopic Scissors | Surgical Innovations Plc | 2006 | — |
| +5 | K090583 | Endoscopic Monopolar Scissors, Models Ems-235, Ems-165 | Apollo Endosurgery, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2024 | 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 FCL? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K973648 | Mini Forceps with HF, 3.5MM; Micro Forceps with HF, 2MM | 1997 | 11 |
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, K973648 (Richard Wolf Medical Instruments Corp., 1997) has gone furthest, with 11 descendants of its own.
How does its category compare?
All FCL devicesFCL Forceps, Biopsy, Non-Electric: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FCL
FDA has decided no FCL device since 2007.
Median 510(k) review, days · FCL
Too few FCL 510(k)s in any year since 2007 to give a median.
Recalls per year · FCL
3in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FCL
55in 2025
MAUDE reports naming product code FCL, 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 | 58 |
| 2008 | 0 | — | 0 | 153 |
| 2009 | 0 | — | 0 | 410 |
| 2010 | 0 | — | 3 | 495 |
| 2011 | 0 | — | 0 | 377 |
| 2012 | 0 | — | 0 | 97 |
| 2013 | 0 | — | 0 | 58 |
| 2014 | 0 | — | 0 | 86 |
| 2015 | 0 | — | 0 | 51 |
| 2016 | 0 | — | 0 | 64 |
| 2017 | 0 | — | 0 | 275 |
| 2018 | 0 | — | 0 | 69 |
| 2019 | 0 | — | 0 | 69 |
| 2020 | 0 | — | 0 | 53 |
| 2021 | 0 | — | 0 | 30 |
| 2022 | 0 | — | 0 | 70 |
| 2023 | 0 | — | 0 | 68 |
| 2024 | 0 | — | 0 | 60 |
| 2025 | 0 | — | 0 | 55 |
| 2026 | 0 | — | 3 | — |
https://510kreport.com/device/K935070 · printed Nov 5, 2026
Cite this page
510(k) Report. “K935070: Grasping Forceps, Biopsy Forceps, Spoon Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K935070
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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