Surgview Integrated Visualization System
by Biovision Technologies, LLC
510(k) K082293
Surgview Integrated Visualization System is a Class II device made by Biovision Technologies, LLC, cleared under FDA 510(k) K082293 on 9 Sep 2008, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK082293 | Date9 Sep 2008 | StatusActive |
Official records
- FDA 510(k) database K082293
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HRX
- Device class
- Class II
- Regulation
- 21 CFR Part 888.1100
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K082293
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| 1.2mm InnerVue II Scope Kit 922180 | BVTKIT72-1R265 / 922180 | 00851582006092 | Outer Diameter 1.2 mm; Angle 10 deg; Length 65 mm | On the market |
| 24-3001 | 24-3001 / 24-3001 | 00841036135010 | On the market | |
| InnerVue II 100mm Scope Kit 922142 | BVTKIT72-1R2A0 / 922142 | 00851582006085 | Length 100 mm; Angle 10 deg; Outer Diameter 1.2 mm | On the market |
| NeedleView 0 Degree 100mm Scope Kit BVTKIT72-0L1A0 | BVTKIT72-0L1A0 / BVTKIT72-0L1A0 | 00851582006139 | Length 100 mm; Angle 0 deg; Outer Diameter 1.2 mm | On the market |
| NeedleView 0 Degree 65mm Scope Kit BVTKIT72-0L165 | BVTKIT72-0L165 / BVTKIT72-0L165 | 00851582006122 | Length 65 mm; Angle 0 deg; Outer Diameter 1.2 mm | On the market |
| NeedleView 10 Degree 100mm Scope Kit BVTKIT72-1R1A0 | BVTKIT72-1R1A0 / BVTKIT72-1R1A0 | 00851582006153 | Length 100 mm; Angle 10 deg; Outer Diameter 1.2 mm | On the market |
| NeedleView 10 Degree 65mm Scope Kit BVTKIT72-1R165 | BVTKIT72-1R165 / BVTKIT72-1R165 | 00851582006146 | Length 65 mm; Angle 10 deg; Outer Diameter 1.2 mm | On the market |
| NeedleView 30 Degree 100mm Scope Kit BVTKIT75-3R1A0 | BVTKIT75-3R1A0 / BVTKIT75-3R1A0 | 00851582006177 | Length 100 mm; Angle 30 deg; Outer Diameter 1.4 mm | On the market |
| NeedleView 30 Degree 65mm Scope Kit BVTKIT75-3R165 | BVTKIT75-3R165 / BVTKIT75-3R165 | 00851582006160 | Length 65 mm; Angle 30 deg; Outer Diameter 1.4 mm | On the market |
| ONPOINT 24-3200 | 24-3200 / 24-3200 | 00841036130244 | On the market | |
| OnPoint Disposable Scope Kit 24-3000 | BVTKIT72-0L065 / 24-3000 | 00851582006023 | Length 65 mm; Angle 0 deg; Outer Diameter 1.2 mm | On the market |
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