510(k) · Cleared
ClearedORISE ProKnife
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Cleared on Dec 3, 2020 as substantially equivalent to K171158 (Olympus Medical Systems Corp., 2017) and 1 other predicate after a 288-day review. Its family tree reaches back 9 generations to 1995.
- Decided
- Dec 3, 2020
- Review
- 288 days
- Class
- Class II
- Product code
- KNS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K952726 (1995). 32 ancestors in all, the oldest K894762 (1989). No later device cites it as a predicate yet.
- Root · 9 generations backK952726 Ultracision Harmonic ScapelUltracision, Inc. · 1995
- 5 generations between
- 3 generations backK083608 Erbe Hybrid KnifeErbe USA, Inc. · 2009
- 2 generations backK143306 ERBE WaterJet Model ERBEJET® 2 System with HybridAPC ProbeErbe USA, Inc. · 2015
- 1 generation backK171158 Single Use Electrosurgical knifeOlympus Medical Systems Corp. · 2017 · Recalled
- This deviceK200404 ORISE ProKnifeBoston Scientific Corporation · 2020
Show all 9 generations
- Root · 9 generations backK952726 Ultracision Harmonic ScapelUltracision, Inc. · 1995
- 8 generations backK990430 Ultracision Harmonic Scalpel Hand PieceEthicon Endo-Surgery, Inc. · 1999
- 7 generations backK012464 Helix Hydro-JetAndreas Pein Medizintechnik GmbH · 2001
- 6 generations backK022613 Helix Hydro-JetErbe USA, Inc. · 2002
- 5 generations backK033590 Erbe Helix Hydro-JetErbe USA, Inc. · 2004
- 4 generations backK062712 Erbe Monopolar Attachment for Helix Hydro-Jet, Model P/N 20139-094Erbe USA, Inc. · 2007
- 3 generations backK083608 Erbe Hybrid KnifeErbe USA, Inc. · 2009
- 2 generations backK143306 ERBE WaterJet Model ERBEJET® 2 System with HybridAPC ProbeErbe USA, Inc. · 2015
- 1 generation backK171158 Single Use Electrosurgical knifeOlympus Medical Systems Corp. · 2017 · Recalled
- This deviceK200404 ORISE ProKnifeBoston Scientific Corporation · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K952726 | Ultracision Harmonic Scapel | Ultracision, Inc. | 1995 | — |
| −8 | K990430 | Ultracision Harmonic Scalpel Hand Piece | Ethicon Endo-Surgery, Inc. | 1999 | — |
| −7 | K012464 | Helix Hydro-Jet | Andreas Pein Medizintechnik GmbH | 2001 | — |
| −6 | K022613 | Helix Hydro-Jet | Erbe USA, Inc. | 2002 | — |
| −5 | K033590 | Erbe Helix Hydro-Jet | Erbe USA, Inc. | 2004 | — |
| −4 | K062712 | Erbe Monopolar Attachment for Helix Hydro-Jet, Model P/N 20139-094 | Erbe USA, Inc. | 2007 | — |
| −3 | K083608 | Erbe Hybrid Knife | Erbe USA, Inc. | 2009 | — |
| −2 | K143306 | ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe | Erbe USA, Inc. | 2015 | — |
| −1 | K171158 | Single Use Electrosurgical knife | Olympus Medical Systems Corp. | 2017 | 2 |
| 0 (this device) | K200404 | ORISE ProKnife | Boston Scientific Corporation | 2020 | — |
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 |
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? (2)
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 |
|---|---|---|---|
| * | K171158 | Single Use Electrosurgical knifeSummary page 4…e Name: Single Use Electrosurgical Knife (Dual Knife J) Manufacturer: Olympus Medical Systems Corp. Clearance Number: K171158 Classification Name: Endoscopic Electrosurgical Unit and Accessories Product Code: KNS Device Class… | 2017 |
| * | K083608 | Erbe Hybrid KnifeSummary page 4…Regulation: 21 CFR 876.4300 Trade Name: ERBE Hybrid Knife Manufacturer: ERBE USA Incorporated Clearance Number: K083608 Classification Name: Jet Lavage Product Code: FQH – Lavage, Jet GEI… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 25 years and passes through 6 companies; a new generation was cleared every 2.6 years on median.
- 4 of the 32 ancestors have a recall of any class.
- 5 other devices also cite its predicate K171158.
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. 2020, 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?
The ORISE™ ProKnife has been designed to be used with endoscopes and electrosurgical units to cut tissue within the gastrointestinal tract using high-frequency current. The electrosurgical knife also has the capability of delivering saline/submucosal lifting agent into submucosal tissue layers under direct visualization through an endoscope.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K200404 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200404: ORISE ProKnife.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200404
Report an extraction error
Are you the manufacturer?
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