510(k) · Cleared
ClearedKoh Micro-Suturing Instruments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KARL STORZ Endoscopy-America, Inc. · OCW Endoscopic Tissue Approximation Device
Cleared on Dec 8, 1995 after an 8-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 18 later devices descend from it.
- Decided
- Dec 8, 1995
- Review
- 8 days
- Class
- Class II
- Product code
- OCW
- Recalls
- None
- Predicates
- 0
18 later devices descend from it, 1 citing it directly.
- This deviceK955479 Koh Micro-Suturing InstrumentsKARL STORZ Endoscopy-America, Inc. · 1995
- Descendant · cites it directly · 17 of its ownK982623 Aesculap Needlescopic Instrument SystemAesculap, Inc. · 1998
- Descendant · 2 generations on · 13 of its ownK123102 Sovereign MiniAesculap, Inc. · 2013
- Descendant · 3 generations on · 8 of its ownK173919 HX DeviceHuman Extension, Ltd. · 2018
- Descendant · 4 generations on · 3 of its ownK203603 Monopolar HookHuman Xtensions, Ltd. · 2021
- Descendant · 3 generations on · 2 of its ownK143299 Percuvance (R) Percutaneous Surgical SystemTeleflexmedical, Inc. · 2015 · Recalled
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K982623Aesculap Needlescopic Instrument SystemAesculap, Inc. · 1998 · cites it directly17descendants
- K123102Sovereign MiniAesculap, Inc. · 2013 · 2 generations on13descendants
- K173919HX DeviceHuman Extension, Ltd. · 2018 · 3 generations on8descendants
- K203603Monopolar HookHuman Xtensions, Ltd. · 2021 · 4 generations on3descendants
- K143299Percuvance (R) Percutaneous Surgical SystemTeleflexmedical, Inc. · 2015 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955479 | Koh Micro-Suturing Instruments | KARL STORZ Endoscopy-America, Inc. | 1995 | — |
| +1 | K982623 | Aesculap Needlescopic Instrument System | Aesculap, Inc. | 1998 | — |
| +2 | K123102 | Sovereign Mini | Aesculap, Inc. | 2013 | — |
| +3 | K173919 | HX Device | Human Extension, Ltd. | 2018 | — |
| +4 | K203603 | Monopolar Hook | Human Xtensions, Ltd. | 2021 | — |
| +3 | K143299 | Percuvance (R) Percutaneous Surgical System | Teleflexmedical, Inc. | 2015 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2018 | 2 | 0 |
| 2021 | 2 | 0 |
| 2023 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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 OCW? 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 OCW device
- #1 K252400 Endomina EZFuse systemscore 12.0 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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? (18)
See all 181 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K982623 | Aesculap Needlescopic Instrument System | 1998 | 17 |
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, K982623 (Aesculap, Inc., 1998) has gone furthest, with 17 descendants of its own.
How does its category compare?
All OCW devicesOCW Endoscopic Tissue Approximation Device: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OCW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OCW
133in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OCW
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OCW
326in 2025
MAUDE reports naming product code OCW, 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 | 5 | 58 | 0 | 9 |
| 2008 | 4 | 70 | 0 | 47 |
| 2009 | 3 | 30 | 0 | 30 |
| 2010 | 4 | 91 | 0 | 10 |
| 2011 | 1 | — | 0 | 16 |
| 2012 | 1 | — | 0 | 28 |
| 2013 | 2 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 28 |
| 2015 | 0 | — | 0 | 59 |
| 2016 | 2 | — | 0 | 74 |
| 2017 | 2 | — | 0 | 420 |
| 2018 | 2 | — | 0 | 413 |
| 2019 | 1 | — | 0 | 291 |
| 2020 | 1 | — | 0 | 183 |
| 2021 | 3 | 221 | 0 | 198 |
| 2022 | 0 | — | 0 | 235 |
| 2023 | 3 | 133 | 1 | 227 |
| 2024 | 0 | — | 0 | 211 |
| 2025 | 1 | — | 0 | 326 |
| 2026 | 2 | — | 3 | — |
https://510kreport.com/device/K955479 · printed Nov 5, 2026
Cite this page
510(k) Report. “K955479: Koh Micro-Suturing Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K955479
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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