Bvi Sling
FDA 510(k) K002233 · Bio-Vascular, Inc.
510(k) numberK002233
Submission
- Device name
- Bvi Sling
- Applicant
- Bio-Vascular, Inc.
St. Paul, MN, US - Received
- July 24, 2000
- Decision date
- October 13, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PAJ – Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3300
- Specialty
- General, Plastic Surgery
- Implant
- Yes
Bridging material to attach the vaginal apex or uterus to the sacral promontory; procedures include abdominal sacrocolpopexy, laparoscopic sacrocolpopexy and robot-assisted sacrocolpopexy.
Other 510(k)s with product code PAJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K051190 | Xenform Soft Tissue Repair MatrixPAJ · Special | Tei Biosciences, Inc. | 06/10/2005SE |
More from Tei Biosciences, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K992537 | Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated and…FTM · Traditional | 02/22/2000SE |
| K983602 | CV Peri-Guard and Vascu-GuardDXZ · Special | 11/12/1998SE |
| K983581 | Ocu-Guard and Ocu-Guard SuppleHQX · Special | 11/06/1998SE |
| K983162 | Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve…FTM · Special | 10/09/1998SE |
| K981624 | Flo-ThruDXC · Traditional | 08/04/1998SE |
| K982282 | Dura-Guard - Dural Repair PatchGXQ · Special | 07/30/1998SE |
| K971726 | CV Peri-Guard - Cardiovascular PatchDXZ · Traditional | 04/10/1998SE |
| K973706 | Dura-Guard-Dural Repair PatchGXQ · Traditional | 12/24/1997SE |
| K973552 | Ocu-Guard Orbital Implant Wrap, Supple Ocu-Guard Orbital Implant WrapMTZ · Traditional | 12/16/1997SE |
| K971048 | Peri-Strips Dry - Staple Line ReinforcementFTM · Traditional | 05/09/1997SE |
Questions and answers
When was Bvi Sling cleared by the FDA?
Bvi Sling (K002233) received a 510(k) decision of Substantially Equivalent on October 13, 2000, 81 days after the submission was received.
What is the product code of K002233?
The FDA product code is PAJ – Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed, a Class II (moderate risk) device regulated under 21 CFR 878.3300.