FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UNIVERSAL COUPLER, LAPAROSCOPIC ACCESSORY
K Number: K912247
·
Decision Nov 13, 1991
Classifications
1
FEI Numbers
548
Registration Numbers
548
Same Product Code
1422
Applicant Total
18
Review Days
176
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Basic Information
- Device Name
- UNIVERSAL COUPLER, LAPAROSCOPIC ACCESSORY
- K Number
- K912247
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Laser Engineering, Inc.
- Date Received
- May 21, 1991
- Decision Date
- November 13, 1991
- Product Code
- GCJ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GCJ | Laparoscope, General & Plastic Surgery | FDA class 2 | Gastroenterology, Urology |
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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 |
| K912347 | BIPURE 1000 | Sep 23, 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 |