GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES— 510(k) K012660
Substantially EquivalentGimmi GmbH
FDA 510(k) clearance K012660 for GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES, Substantially Equivalent on 2001-12-20. Applicant: Gimmi GmbH. Device class: 2.
Clearance details
- Applicant
- Gimmi GmbH
- Product code
- Code FET
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Amsterdam, Nh, NL
Recent devices under product code FET
view allMore clearances from Gimmi GmbH
view all- K261179 — AlphaTriPart - Monopolar MIC Instruments
- K092421 — ALPHAHYSTEROSCOPE, FIBEROPTIC, OPERATIVE AND DIAGNOSTIC
- K093125 — ALPHAXENON LIGHT 180 W AND 300 W
- K081640 — GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS
- K012869 — GIMMI ALPHA HYSTEROSCOPES & ACCESSORIES, MODELS E.8XXX.XX, T.8XXX.XX, ZXXX.XX,S.XXXX.XX, K0142.25
Adverse events under product code FET
product code FET- Injury
- 313
- Malfunction
- 54,276
- Total
- 54,589
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K012660
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K012660.
Data sourced from openFDA. This site is unofficial and independent of the FDA.