510(k) · Cleared
Recalled · Class II · 2024Gimmi'alpha' Endoscopes & Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gimmi GmbH · FET Endoscopic Video Imaging System/Component, Gastroenterology-Urology
Cleared on Dec 20, 2001 after a 129-day review. The FDA summary names its predicate without a number. 6 later devices descend from it. It has been recalled once.
- Decided
- Dec 20, 2001
- Review
- 129 days
- Class
- Class II
- Product code
- FET
- Recalls
- 1
- Predicates
- 0
6 later devices descend from it, 4 citing it directly.
- This deviceK012660 Gimmi'alpha' Endoscopes & AccessoriesGimmi GmbH · 2001
- Descendant · cites it directly · 2 of its ownK040855 Instrumed Laparoscope and AccessoriesInstrumed International, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK080257 Microfrance Laparoscopic Manual Surgical InstrumentsMedtronic Xomed, Inc. · 2008
- Descendant · 2 generations on · 1 of its ownK080051 Virtual Ports Endoclear SystemVirtual Ports, Ltd. · 2008
- Descendant · cites it directly · 0 of its ownK113062 Endoservice Endoscopic Instruments & Accessories and Minimally…Endoservice Optical Instruments GmbH · 2012
- Descendant · cites it directly · 0 of its ownK101193 PMC Laparoscopic InstrumentsPmc Medical GmbH · 2010
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K040855Instrumed Laparoscope and AccessoriesInstrumed International, Inc. · 2004 · cites it directly2descendants
- K080257Microfrance Laparoscopic Manual Surgical InstrumentsMedtronic Xomed, Inc. · 2008 · cites it directly1descendant
- K080051Virtual Ports Endoclear SystemVirtual Ports, Ltd. · 2008 · 2 generations on1descendant
- K113062Endoservice Endoscopic Instruments & Accessories and Minimally Invasive GI and GU DevicesEndoservice Optical Instruments GmbH · 2012 · cites it directly0descendants
- K101193PMC Laparoscopic InstrumentsPmc Medical GmbH · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012660 | Gimmi'alpha' Endoscopes & Accessories | Gimmi GmbH | 2001 | — |
| +1 | K040855 | Instrumed Laparoscope and Accessories | Instrumed International, Inc. | 2004 | — |
| +1 | K080257 | Microfrance Laparoscopic Manual Surgical Instruments | Medtronic Xomed, Inc. | 2008 | — |
| +2 | K080051 | Virtual Ports Endoclear System | Virtual Ports, Ltd. | 2008 | — |
| +1 | K113062 | Endoservice Endoscopic Instruments & Accessories and Minimally Invasive GI and… | Endoservice Optical Instruments GmbH | 2012 | — |
| +1 | K101193 | PMC Laparoscopic Instruments | Pmc Medical GmbH | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 2 | 0 |
| 2010 | 2 | 0 |
| 2012 | 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 FET? 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 FET device
- #1 K242067 Visera Elite Iii Video System Center Olympus…score 18.4 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (13)
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 |
|---|---|---|---|
| * | — | Ginter Bissinger Medizintechnik Named without a submission number | |
| * | — | Comeg Endoscopy Named without a submission number | |
| * | — | Dufner instrumente GmbH Named without a submission number | |
| * | — | Henke-Sass Wolf, GmbH Named without a submission number | |
| * | — | Optus, Inc. Named without a submission number | |
| * | — | Pilling Weck Group Named without a submission number | |
| * | — | Wolf Named without a submission number | |
| * | — | Karl Storz Endoscopy Named without a submission number | |
| * | — | Jarit (J. Jamner Surgical Instruments, Inc.) Named without a submission number | |
| * | — | Snowden-Pencer, Inc. Named without a submission number | |
| * | — | SurgiTech, Inc. (Surgical Technologies International, Inc.) Named without a submission number | |
| * | — | United States Surgical Corp. Named without a submission number | |
| * | — | Allegiance Healthcare Corp. Named without a submission number |
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 3, 2024 | Class II | Z-0940-2025 | Under Investigation by firm | Reports of various packaging issues that may result in a breach of the sterile barrier. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K040855 (Instrumed International, Inc., 2004) has gone furthest, with 2 descendants of its own.
How does its category compare?
All FET devicesFET Endoscopic Video Imaging System/Component, Gastroenterology-Urology: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FET
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FET
166in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FET
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FET
14,530in 2025
MAUDE reports naming product code FET, 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 | — | 0 | 2 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 6 |
| 2010 | 1 | — | 0 | 3 |
| 2011 | 2 | — | 0 | 7 |
| 2012 | 2 | — | 0 | 11 |
| 2013 | 2 | — | 0 | 8 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 2 | — | 0 | 3 |
| 2016 | 1 | — | 0 | 25 |
| 2017 | 3 | 119 | 0 | 66 |
| 2018 | 3 | 98 | 0 | 67 |
| 2019 | 3 | 25 | 0 | 72 |
| 2020 | 5 | 106 | 0 | 3,043 |
| 2021 | 1 | — | 0 | 5,300 |
| 2022 | 2 | — | 0 | 6,156 |
| 2023 | 1 | — | 2 | 8,199 |
| 2024 | 2 | — | 1 | 13,153 |
| 2025 | 6 | 166 | 0 | 14,530 |
| 2026 | 3 | 69 | 0 | — |
What is it indicated for?
GIMMI ALPHA® Gastro-Urology and Laparoscopic Endoscopes, Endoscopic Accessories and GIMMI devices for minimally invasive gastrointestinal (GI), genitourinary (GU), and laparoscopic diagnostic and/or therapeutic indications are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/urologic and minimally invasive procedures.
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/K012660 · printed Nov 5, 2026
Cite this page
510(k) Report. “K012660: Gimmi'alpha' Endoscopes & Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K012660
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026