FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
BELLOTA SONOHYSTEROGRAPHY CATHETER WITH CERVICAL CONE, BELLOTA SONOHYSTEROGRAPHY CATHETER WITHOUT CERVICAL CONE
K Number: K102898
·
Decision Dec 15, 2011
Classifications
1
FEI Numbers
78
Registration Numbers
78
Same Product Code
86
Applicant Total
12
Review Days
441
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Basic Information
- Device Name
- BELLOTA SONOHYSTEROGRAPHY CATHETER WITH CERVICAL CONE, BELLOTA SONOHYSTEROGRAPHY CATHETER WITHOUT CERVICAL CONE
- K Number
- K102898
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4530
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Panpac Medical Corporation
- Date Received
- September 30, 2010
- Decision Date
- December 15, 2011
- Product Code
- LKF
- 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 |
|---|---|---|---|
| LKF | Cannula, Manipulator/Injector, Uterine | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by Panpac Medical Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K173351 | Panpac Flexi Shelf Pessary | Oct 31, 2018 | Substantially Equivalent |
| K161106 | PANPAC DISPOSABLE VACUUM CURETTES | Jan 13, 2017 | Substantially Equivalent |
| K153422 | Panpac Disposable Pessary Fitting Set | Jul 14, 2016 | Substantially Equivalent |
| K132670 | PANPAC INFLATABLE DOCUT PESSARY | Jun 4, 2014 | Substantially Equivalent |
| K130087 | PANPAC WORD/BARTHOLIN CATHETER | Jan 10, 2014 | Substantially Equivalent |
| K130273 | PANPAC VAGINAL DILATORS | Aug 8, 2013 | Substantially Equivalent |
| K092982 | THE PANPAC SUCTION CURETTE | Jul 26, 2010 | Substantially Equivalent |
| K092981 | PANPAC VAGINAL PESSARY | Jul 22, 2010 | Substantially Equivalent |
| K092983 | PANPAC HSG CATHETER SET | Jun 7, 2010 | Substantially Equivalent |
| K092984 | PANPAC UTERINE INECTOR, MODEL UI-4.0, UI-2.0 | Apr 7, 2010 | Substantially Equivalent |