510(k) · Cleared
ClearedElectrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hangzhou AGS MedTech Co., Ltd. · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Cleared on May 21, 2020 as substantially equivalent to K083452 (Erbe USA, Inc., 2008) and 3 other predicates after a 267-day review. Its family tree reaches back 9 generations to 1995.
- Decided
- May 21, 2020
- Review
- 267 days
- Class
- Class II
- Product code
- KNS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K952726 (1995). 40 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 deviceK192342 Electrosurgical System (Electrosurgical Generator with Bipolar…Hangzhou AGS MedTech Co., Ltd. · 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 deviceK192342 Electrosurgical System (Electrosurgical Generator with Bipolar…Hangzhou AGS MedTech Co., Ltd. · 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) | K192342 | Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy… | Hangzhou AGS MedTech Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 5 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2018 | 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? (4)
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 |
|---|---|---|---|
| * | K083452 | Erbe Model Vio 300 D with AccessoriesSummary page 4…sories Device Name: ERBE ESU Model VIO 300D with Accessories Common Name: Electrosurgical Unit (ESU/Generator) System 510(k) Number: K083452 Regulation class: Class II Regulation Number: 21 CFR 878.4400 Regulation Description: Electrosurgical cutting an… | 2008 |
| * | K172729 | Polypectomy SnareSummary page 5…ccessories Trade Name: Polypectomy snare Device Name: Polypectomy snare Common Name: Polypectomy snare 510(k) Number: K172729 Regulation class: Class II Regulation Number: 21 CFR 876.4300 Regulation Description: Endoscopic electrosurgical… | 2018 |
| * | K092309 | Single Use Electrosurgical Knife Series, Model KD-610L, KD-611L, KD-620LR, KD-630L…Summary page 5…Electrosurgical Knife Series Device Name: Single use Electrosurgical Knife Series Common Name: Electrosurgical Knife 510(k) Number: K092309 Regulation class: Class II Regulation Number: 21 CFR 876.4300 Regulation Description: Endoscopic electrosurgical… | 2009 |
| * | K171158 | Single Use Electrosurgical knifeSummary page 5…use Electrosurgical knife Device Name: Single use Electrosurgical knife Common Name: Single use Electrosurgical knife 510(k) Number: K171158 Regulation class: Class II Regulation Number: 21 CFR 876.4300 Regulation Description: Endoscopic electrosurgical… | 2017 |
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.
- 8 of the 40 ancestors have a recall of any class.
- 9 other devices also cite its predicate K083452.
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?
Electrosurgical Generator is intended to deliver High Frequency (HF) electrical current for the cutting and/or coagulation of tissue.
Bipolar Polypectomy Snare Combination has been designed to be used with endoscope and electrosurgical unit for the removal of sessile polyps, pedunculated polyps, tissue and foreign bodies from within the GI tract using high-frequency current.
Single Use Electrosurgical Knife Combination has been designed to be used with endoscopes and electrosurgical units to cut tissue within the digestive tract using high-frequency current.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192342 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192342: Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192342
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