FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIPURE 1000
K Number: K912347
·
Decision Sep 23, 1991
Classifications
1
FEI Numbers
73
Registration Numbers
73
Same Product Code
74
Applicant Total
18
Review Days
118
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- BIPURE 1000
- K Number
- K912347
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5070
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Laser Engineering, Inc.
- Date Received
- May 28, 1991
- Decision Date
- September 23, 1991
- Product Code
- FYD
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FYD | Apparatus, Exhaust, Surgical | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FYD), ordered by most recent decision date.
PlumeSafe X5 Smoke Management System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
8Q10 Surclear Smoke Plume Evacuation System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Medline Smoke Evacuation Shroud
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NEBULAE SRS Laparoscopic Surgical Smoke Removal System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
EvaQMax Smoke Evacuation System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Laser Engineering, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K211605 | Dual Switch | Sep 22, 2022 | Substantially Equivalent |
| K141908 | DUAL SWITCH | Oct 22, 2014 | Substantially Equivalent |
| K924457 | MICROMANIPULATOR | May 7, 1993 | Substantially Equivalent |
| K912247 | UNIVERSAL COUPLER, LAPAROSCOPIC ACCESSORY | Nov 13, 1991 | Substantially Equivalent |
| K910062 | 02-10,001 | Aug 16, 1991 | Substantially Equivalent |
| K911852 | COMPULSE CO2 SURGICAL LASER SYS. | Jun 7, 1991 | Substantially Equivalent |
| K905676 | MD CO2 SURGICAL LASER SYSTEM/GEN. SURGERY AND ORTH | Apr 22, 1991 | Substantially Equivalent |
| K875314 | GL-35 COLPOSCOPIC LASER SYSTEM | Aug 5, 1988 | Substantially Equivalent |
| K881587 | MODEL MD-25 CO2 LASER FOR PODIATRY APPLICATIONS | Jun 3, 1988 | Substantially Equivalent |
| K881580 | MODEL MD-25 CO2 LASER FOR DERMA./PLASTIC SURGERY | Jun 3, 1988 | Substantially Equivalent |