FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
DISPOSABLE SUCTION AND IRRIGATION SYSTEM
K Number: K093479
·
Decision May 19, 2010
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
2
Applicant Total
14
Review Days
191
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Basic Information
- Device Name
- DISPOSABLE SUCTION AND IRRIGATION SYSTEM
- K Number
- K093479
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.4370
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Modern Medical Equipment Mfg., Ltd.
- Date Received
- November 9, 2009
- Decision Date
- May 19, 2010
- Product Code
- FHF
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FHF | System, Evacuator, Fluid | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FHF), ordered by most recent decision date.
SUCTION IRRIGATOR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CATHETER, MEDIASTINAL&PERICARDIAL
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Modern Medical Equipment Mfg., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K091511 | MODERN MEDICAL RESECTOSCOPE ELECTRODES | Jan 15, 2010 | Substantially Equivalent |
| K070812 | DISPOSABLE LAPAROSCOPIC INSTRUMENT | Sep 14, 2007 | Substantially Equivalent |
| K070877 | ENDOCERVICAL ELECTRODE # 2 | Jul 27, 2007 | Substantially Equivalent |
| K050842 | AGCEL WOUND DRESSING,AGCEL BURN DRESSING | Aug 2, 2006 | Substantially Equivalent |
| K043036 | NON-STICK ELECTRODE | May 6, 2005 | Substantially Equivalent |
| K033095 | SMOKE EVACUATION ATTACHEMENT | Nov 17, 2004 | Substantially Equivalent |
| K040238 | SOFTSEAL HSG CATHETER | Jun 22, 2004 | Substantially Equivalent |
| K032327 | MODERN MEDICAL BIPOLAR FORCEPS | Jun 15, 2004 | Substantially Equivalent |
| K030831 | LAPASCOPIC INSTRUMENTS AND ELECTRODE TIPS | Jun 15, 2004 | Substantially Equivalent |
| K033003 | SUCTION COAGULATOR | May 13, 2004 | Substantially Equivalent |