510(k) · Cleared
ClearedDisposable Hot Biopsy Forceps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro-Tech (Nanjing) Co., Ltd. · KGE Forceps, Biopsy, Electric
Cleared on Jul 5, 2018 as substantially equivalent to K160625 (Micro-Tech (Nanjing) Co., Ltd., 2016) after a 184-day review. Its family tree reaches back 3 generations to 1987.
- Decided
- Jul 5, 2018
- Review
- 184 days
- Class
- Class II
- Product code
- KGE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K874314 (1987). No later device cites it as a predicate yet.
- Root · 3 generations backK874314 Wilson-Cook Biopsy ForcepsWilson-Cook Medical, Inc. · 1987
- 2 generations backK953355 Gip/Meid-Globe Hot Biopsy ForcepsMedi-Globe Corp. · 1996
- 1 generation backK160625 Disposable Hot Biopsy ForcepsMicro-Tech (Nanjing) Co., Ltd. · 2016
- This deviceK180018 Disposable Hot Biopsy ForcepsMicro-Tech (Nanjing) Co., Ltd. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K874314 | Wilson-Cook Biopsy Forceps | Wilson-Cook Medical, Inc. | 1987 | — |
| −2 | K953355 | Gip/Meid-Globe Hot Biopsy Forceps | Medi-Globe Corp. | 1996 | — |
| −1 | K160625 | Disposable Hot Biopsy Forceps | Micro-Tech (Nanjing) Co., Ltd. | 2016 | — |
| 0 (this device) | K180018 | Disposable Hot Biopsy Forceps | Micro-Tech (Nanjing) Co., Ltd. | 2018 | — |
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 KGE? 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 KGE device
- #1 K251807 Single Use Electrosurgical Hemostatic Forceps…score 11.6 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K160625 | Disposable Hot Biopsy ForcepsSummary page 4…cessories Classification: 2 Product Code: KGE Regulation Number: 876.4300 Review Panel: Gastroenterology/Urology 4. Identification of Predicate Device 510(k) Number: K160625 Trade Name: Disposable Hot Biopsy Forceps Common Name: Forceps, Biopsy, Electric 5. Indications for Use This device is used f… | 2016 |
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 31 years and passes through 3 companies; a new generation was cleared every 8.3 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K160625.
How does its category compare?
All KGE devicesKGE Forceps, Biopsy, Electric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · KGE
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KGE
184in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KGE
No recall names KGE since 2007.
Adverse event reports per year · KGE
10in 2025
MAUDE reports naming product code KGE, 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 | 4 |
| 2008 | 0 | — | 0 | 15 |
| 2009 | 2 | — | 0 | 75 |
| 2010 | 1 | — | 0 | 29 |
| 2011 | 0 | — | 0 | 51 |
| 2012 | 0 | — | 0 | 30 |
| 2013 | 1 | — | 0 | 14 |
| 2014 | 1 | — | 0 | 12 |
| 2015 | 0 | — | 0 | 15 |
| 2016 | 3 | 102 | 0 | 9 |
| 2017 | 2 | — | 0 | 26 |
| 2018 | 3 | 184 | 0 | 26 |
| 2019 | 1 | — | 0 | 15 |
| 2020 | 0 | — | 0 | 7 |
| 2021 | 2 | — | 0 | 24 |
| 2022 | 1 | — | 0 | 16 |
| 2023 | 1 | — | 0 | 8 |
| 2024 | 0 | — | 0 | 9 |
| 2025 | 2 | — | 0 | 10 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
This device is used for endoscopic histological sampling or electrocoagulation of various tissues, within the gastrointestinal and bronchial tracts, via the operating channel of endoscopic instruments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180018 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180018: Disposable Hot Biopsy Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180018
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