FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODULAP LOOP
K Number: K121343
·
Decision Jun 14, 2013
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
43
Applicant Total
4
Review Days
406
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MODULAP LOOP
- K Number
- K121343
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4160
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Atc Technologies, Inc.
- Date Received
- May 4, 2012
- Decision Date
- June 14, 2013
- Product Code
- KNF
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| KNF | Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KNF), ordered by most recent decision date.
Sonata Transcervical Fibroid Ablation System 2.2
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Sonata Transcervical Fibroid Ablation System 2.2
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Sonata Transcervical Fibroid Ablation System 2.2
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Sonata Transcervical Fibroid Ablation System 2.2
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology