510(k) · Cleared
Recalled · Class II · 2021Single Use Electrosurgical knife
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corp. · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Cleared on Nov 17, 2017 as substantially equivalent to K092309 (Olympus Medical Systems Corporation, 2009) and 2 other predicates after a 211-day review. Its family tree reaches back 8 generations to 1995. 7 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 17, 2017
- Review
- 211 days
- Class
- Class II
- Product code
- KNS
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 8 generations to K952726 (1995). 31 ancestors in all, the oldest K894762 (1989). 7 later devices descend from it, 6 citing it directly.
- Root · 8 generations backK952726 Ultracision Harmonic ScapelUltracision, Inc. · 1995
- 7 generations backK990430 Ultracision Harmonic Scalpel Hand PieceEthicon Endo-Surgery, Inc. · 1999
- 6 generations backK012464 Helix Hydro-JetAndreas Pein Medizintechnik GmbH · 2001
- 5 generations backK022613 Helix Hydro-JetErbe USA, Inc. · 2002
- 4 generations backK033590 Erbe Helix Hydro-JetErbe USA, Inc. · 2004
- 3 generations backK062712 Erbe Monopolar Attachment for Helix Hydro-Jet, Model P/N 20139-094Erbe USA, Inc. · 2007
- 2 generations backK083608 Erbe Hybrid KnifeErbe USA, Inc. · 2009
- 1 generation backK143306 ERBE WaterJet Model ERBEJET® 2 System with HybridAPC ProbeErbe USA, Inc. · 2015
- This deviceK171158 Single Use Electrosurgical knifeOlympus Medical Systems Corp. · 2017
- Descendant · cites it directly · 1 of its ownK193601 Single Use Electrosurgical KnifeMicro-Tech (Nanjing) Co., Ltd. · 2020
- Descendant · cites it directly · 1 of its ownK182408 Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical…Olympus Medical Systems Corp. · 2019 · Recalled
- Descendant · cites it directly · 0 of its ownK250351 Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use…Olympus Medical Systems Corporation · 2025
- Descendant · cites it directly · 0 of its ownK212999 Multi-Functional Electrosurgical KnifeAnrei Medical (Hangzhou) Co., Ltd. · 2022
- Descendant · 2 generations on · 0 of its ownK211172 Single Use Electrosurgical Knife with Fluid Pump SystemMicro-Tech (Nanjing) Co., Ltd. · 2021
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K193601Single Use Electrosurgical KnifeMicro-Tech (Nanjing) Co., Ltd. · 2020 · cites it directly1descendant
- K182408Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645Olympus Medical Systems Corp. · 2019 · cites it directly1descendant
- K250351Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife…Olympus Medical Systems Corporation · 2025 · cites it directly0descendants
- K212999Multi-Functional Electrosurgical KnifeAnrei Medical (Hangzhou) Co., Ltd. · 2022 · cites it directly0descendants
- K211172Single Use Electrosurgical Knife with Fluid Pump SystemMicro-Tech (Nanjing) Co., Ltd. · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K952726 | Ultracision Harmonic Scapel | Ultracision, Inc. | 1995 | — |
| −7 | K990430 | Ultracision Harmonic Scalpel Hand Piece | Ethicon Endo-Surgery, Inc. | 1999 | — |
| −6 | K012464 | Helix Hydro-Jet | Andreas Pein Medizintechnik GmbH | 2001 | — |
| −5 | K022613 | Helix Hydro-Jet | Erbe USA, Inc. | 2002 | — |
| −4 | K033590 | Erbe Helix Hydro-Jet | Erbe USA, Inc. | 2004 | — |
| −3 | K062712 | Erbe Monopolar Attachment for Helix Hydro-Jet, Model P/N 20139-094 | Erbe USA, Inc. | 2007 | — |
| −2 | K083608 | Erbe Hybrid Knife | Erbe USA, Inc. | 2009 | — |
| −1 | K143306 | ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe | Erbe USA, Inc. | 2015 | — |
| 0 (this device) | K171158 | Single Use Electrosurgical knife | Olympus Medical Systems Corp. | 2017 | — |
| +1 | K193601 | Single Use Electrosurgical Knife | Micro-Tech (Nanjing) Co., Ltd. | 2020 | — |
| +1 | K182408 | Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife… | Olympus Medical Systems Corp. | 2019 | 3 |
| +1 | K250351 | Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use… | Olympus Medical Systems Corporation | 2025 | — |
| +1 | K212999 | Multi-Functional Electrosurgical Knife | Anrei Medical (Hangzhou) Co., Ltd. | 2022 | — |
| +2 | K211172 | Single Use Electrosurgical Knife with Fluid Pump System | Micro-Tech (Nanjing) Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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 KNS? 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 KNS device
- #1 K241271 Aqua Medical RF Vapor Ablation Systemscore 17.2 · 20 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K092309 | Single Use Electrosurgical Knife Series, Model KD-610L, KD-611L, KD-620LR, KD-630L…Summary page 5…e Device1 Device name Applicant 510(k)# SINGLE USE OLYMPUS MEDICAL K092309 ELECTROSURGICAL KNIFE SYSTEMS CORPORATION SERIES Additional Predicate Device2 Device name… | 2009 |
| * | K143306 | ERBE WaterJet Model ERBEJET® 2 System with HybridAPC ProbeSummary page 5…e Device2 Device name Applicant 510(k)# ERBE WaterJet Model ERBE USA, INC. K143306 ERBEJET®2 System with HybridAPC Probe Additional Predicate Device3 Device name Applicant… | 2015 |
| * | K083608 | Erbe Hybrid KnifeSummary page 5…e Device3 Device name Applicant 510(k)# ERBE HYBRID KNIFE ERBE USA, INC. K083608 IV. Device Description The subject device is an endoscopic electrosurgical knife incorporating the saline feeding function for E… | 2009 |
What descends from it? (7)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193601 | Single Use Electrosurgical Knife | 2020 | 1 |
| K182408 | Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645 | 2019 | 1 |
| K250351 | Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife… | 2025 | 0 |
| K212999 | Multi-Functional Electrosurgical Knife | 2022 | 0 |
| K200404 | ORISE ProKnife | 2020 | 0 |
| K192342 | Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare… | 2020 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 4, 2021 | Class II | Z-0983-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-0982-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- 3 of the 31 ancestors have a recall of any class.
- Of its descendants, K193601 (Micro-Tech (Nanjing) Co., Ltd., 2020) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K092309.
How does its category compare?
All KNS devicesKNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · KNS
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNS
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNS
14in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KNS
1,504in 2025
MAUDE reports naming product code KNS, 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 | 1 | — | 3 | 164 |
| 2008 | 3 | 61 | 5 | 587 |
| 2009 | 3 | 212 | 2 | 1,027 |
| 2010 | 4 | 168 | 0 | 908 |
| 2011 | 1 | — | 2 | 860 |
| 2012 | 2 | — | 0 | 848 |
| 2013 | 2 | — | 0 | 449 |
| 2014 | 1 | — | 0 | 405 |
| 2015 | 3 | 252 | 0 | 406 |
| 2016 | 3 | 30 | 6 | 457 |
| 2017 | 3 | 48 | 1 | 446 |
| 2018 | 5 | 62 | 0 | 563 |
| 2019 | 7 | 66 | 0 | 668 |
| 2020 | 4 | 212 | 0 | 906 |
| 2021 | 4 | 139 | 41 | 814 |
| 2022 | 3 | 182 | 0 | 913 |
| 2023 | 9 | 83 | 0 | 976 |
| 2024 | 3 | 198 | 14 | 1,533 |
| 2025 | 11 | 171 | 0 | 1,504 |
| 2026 | 2 | — | 4 | — |
What is it indicated for?
These instruments have been designed to be used with Olympus endoscopes and electrosurgical units to cut tissue within the digestive tract using high-frequency current.
These instruments are indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions using direct visualization through an endoscope.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171158 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171158: Single Use Electrosurgical knife.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171158
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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