FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BVI SLING
K Number: K002233
·
Decision Oct 13, 2000
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
1
Applicant Total
26
Review Days
81
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Basic Information
- Device Name
- BVI SLING
- K Number
- K002233
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.3300
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bio-Vascular, Inc.
- Date Received
- July 24, 2000
- Decision Date
- October 13, 2000
- Product Code
- PAJ
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| PAJ | Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PAJ), ordered by most recent decision date.
View allOther Clearances by Bio-Vascular, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K992537 | PERI-STRIPS-SLEEVE, PERI-STRIPS-STRIP AND PERI-STRIPS DRY (NON-NAOH-TREATED AND NAOH-TREATED | Feb 22, 2000 | Substantially Equivalent |
| K983602 | CV PERI-GUARD AND VASCU-GUARD | Nov 12, 1998 | Substantially Equivalent |
| K983581 | OCU-GUARD AND OCU-GUARD SUPPLE | Nov 6, 1998 | Substantially Equivalent |
| K983162 | PERI-GUARD, CV PERI-GUARD, OCU-GUARD, SUPPLE PERI-GUARD, PERI-STRIPS - SLEEVE, PERI-STRIPS-STRIPS, PERI-STRIPS DRY, VASC | Oct 9, 1998 | Substantially Equivalent |
| K981624 | FLO-THRU | Aug 4, 1998 | Substantially Equivalent |
| K982282 | DURA-GUARD - DURAL REPAIR PATCH | Jul 30, 1998 | Substantially Equivalent |
| K971726 | CV PERI-GUARD - CARDIOVASCULAR PATCH | Apr 10, 1998 | Substantially Equivalent |
| K973706 | DURA-GUARD-DURAL REPAIR PATCH | Dec 24, 1997 | Substantially Equivalent |
| K973552 | OCU-GUARD ORBITAL IMPLANT WRAP, SUPPLE OCU-GUARD ORBITAL IMPLANT WRAP | Dec 16, 1997 | Substantially Equivalent |
| K971048 | PERI-STRIPS DRY - STAPLE LINE REINFORCEMENT | May 9, 1997 | Substantially Equivalent |