FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇱 Netherlands
GIMMI ALPHA SINUSCOPES MODEL # E.8282.01/31/71 + E.8284.01/31/71; GIMMI ALPHA BRONCHOSCOPES MODEL # E.8189.00/01/02/03
K Number: K013731
·
Decision Nov 27, 2001
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
238
Applicant Total
6
Review Days
18
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Basic Information
- Device Name
- GIMMI ALPHA SINUSCOPES MODEL # E.8282.01/31/71 + E.8284.01/31/71; GIMMI ALPHA BRONCHOSCOPES MODEL # E.8189.00/01/02/03
- K Number
- K013731
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 874.4680
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Gimmi GmbH
- Date Received
- November 9, 2001
- Decision Date
- November 27, 2001
- Product Code
- EOQ
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| EOQ | Bronchoscope (Flexible Or Rigid) | FDA class 2 | Ear, Nose, Throat |
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Other Clearances by Gimmi GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K092421 | ALPHAHYSTEROSCOPE, FIBEROPTIC, OPERATIVE AND DIAGNOSTIC | Feb 12, 2010 | Substantially Equivalent |
| K093125 | ALPHAXENON LIGHT 180 W AND 300 W | Jan 27, 2010 | Substantially Equivalent |
| K081640 | GIMMI ANEURYSM CLIPS AND APPLYING FORCEPS | May 6, 2009 | Substantially Equivalent |
| K012869 | GIMMI ALPHA HYSTEROSCOPES & ACCESSORIES, MODELS E.8XXX.XX, T.8XXX.XX, ZXXX.XX,S.XXXX.XX, K0142.25 | Mar 11, 2002 | Substantially Equivalent |
| K012660 | GIMMI'ALPHA' ENDOSCOPES & ACCESSORIES | Dec 20, 2001 | Substantially Equivalent |