510(k) · Cleared
ClearedGip/Meid-Globe Hot Biopsy Forceps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medi-Globe Corp. · KGE Forceps, Biopsy, Electric
Cleared on Apr 4, 1996 as substantially equivalent to K874314 (Wilson-Cook Medical, Inc., 1987) after a 262-day review. Its family tree reaches back 1 generation to 1987. 3 later devices descend from it.
- Decided
- Apr 4, 1996
- Review
- 262 days
- Class
- Class II
- Product code
- KGE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K874314 (1987). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK874314 Wilson-Cook Biopsy ForcepsWilson-Cook Medical, Inc. · 1987
- This deviceK953355 Gip/Meid-Globe Hot Biopsy ForcepsMedi-Globe Corp. · 1996
- Descendant · cites it directly · 2 of its ownK160625 Disposable Hot Biopsy ForcepsMicro-Tech (Nanjing) Co., Ltd. · 2016
- Descendant · 2 generations on · 0 of its ownK173495 Single Use Hot Biopsy Forceps FD-231Olympus Medical Systems Corp. · 2018
- Descendant · 2 generations on · 0 of its ownK180018 Disposable Hot Biopsy ForcepsMicro-Tech (Nanjing) Co., Ltd. · 2018
Most influential descendants
Showing 3 of 3 · See all- K160625Disposable Hot Biopsy ForcepsMicro-Tech (Nanjing) Co., Ltd. · 2016 · cites it directly2descendants
- K173495Single Use Hot Biopsy Forceps FD-231Olympus Medical Systems Corp. · 2018 · 2 generations on0descendants
- K180018Disposable Hot Biopsy ForcepsMicro-Tech (Nanjing) Co., Ltd. · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K874314 | Wilson-Cook Biopsy Forceps | Wilson-Cook Medical, Inc. | 1987 | — |
| 0 (this device) | K953355 | Gip/Meid-Globe Hot Biopsy Forceps | Medi-Globe Corp. | 1996 | — |
| +1 | K160625 | Disposable Hot Biopsy Forceps | Micro-Tech (Nanjing) Co., Ltd. | 2016 | — |
| +2 | K173495 | Single Use Hot Biopsy Forceps FD-231 | Olympus Medical Systems Corp. | 2018 | — |
| +2 | K180018 | Disposable Hot Biopsy Forceps | Micro-Tech (Nanjing) Co., Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 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 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 |
|---|---|---|---|
| * | K874314 | Wilson-Cook Biopsy ForcepsSummary page 1…ed endoscopes (reference Pentax’s FDA registered endoscope K792215 and K792267, Olympus’ endoscope K790071). The 510(k) number for the Wilson Cook Hot Biopsy Forceps is K874314. A detailed list of GIP/Medi-Globe Hot Biopsy Forceps is presented in Exhibit D for comparison. The intended use of the GIP Medi-… | 1987 |
| † | K792215 | Pentex Upper G.I. Scope Model FG-28A | 1979 |
| † | K792267 | Pentex Bronchofiberscope Model FB-17A | 1979 |
| † | K790071 | Endoscope and Accessories | 1979 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160625 | Disposable Hot Biopsy Forceps | 2016 | 2 |
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?
- Its one ancestor has no recall.
- Of its descendants, K160625 (Micro-Tech (Nanjing) Co., Ltd., 2016) has gone furthest, with 2 descendants of its own.
How does its category compare?
All KGE devicesKGE Forceps, Biopsy, Electric: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The intended use of the GIP Medi-Globe Hot Biopsy Forceps is identical to the Wilson-Cook device for removal of small polyps in the GI track.
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/K953355 · printed Nov 5, 2026
Cite this page
510(k) Report. “K953355: Gip/Meid-Globe Hot Biopsy Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K953355
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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