# K012660: Gimmi'alpha' Endoscopes & Accessories

- Pathway: 510(k) (Abbreviated)
- Applicant: Gimmi GmbH
- Decided: Dec 20, 2001 after 129 days
- Product code: FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 4 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Ginter Bissinger Medizintechnik: named in the summary without a submission number
- (no number) Comeg Endoscopy: named in the summary without a submission number
- (no number) Dufner instrumente GmbH: named in the summary without a submission number
- (no number) Henke-Sass Wolf, GmbH: named in the summary without a submission number
- (no number) Optus, Inc.: named in the summary without a submission number
- (no number) Pilling Weck Group: named in the summary without a submission number
- (no number) Wolf: named in the summary without a submission number
- (no number) Karl Storz Endoscopy: named in the summary without a submission number
- (no number) Jarit (J. Jamner Surgical Instruments, Inc.): named in the summary without a submission number
- (no number) Snowden-Pencer, Inc.: named in the summary without a submission number
- (no number) SurgiTech, Inc. (Surgical Technologies International, Inc.): named in the summary without a submission number
- (no number) United States Surgical Corp.: named in the summary without a submission number
- (no number) Allegiance Healthcare Corp.: named in the summary without a submission number

## Most influential descendants
- K040855: Instrumed Laparoscope and Accessories (2004), 2 descendants of its own
- K080257: Microfrance Laparoscopic Manual Surgical Instruments (2008), 1 descendant of its own
- K080051: Virtual Ports Endoclear System (2008), 1 descendant of its own
- K113062: Endoservice Endoscopic Instruments & Accessories and Minimally Invasive GI and GU Devices (2012), 0 descendants of its own
- K101193: PMC Laparoscopic Instruments (2010), 0 descendants of its own

## Recalls of this device
- Dec 3, 2024 · Class II · Z-0940-2025: Reports of various packaging issues that may result in a breach of the sterile barrier.

## Indications for use
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.

Source page: https://510kreport.com/device/K012660
Methodology: https://510kreport.com/methodology