FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ONE INCISION BI-POLAR ELECTRO. FORCEPS
K Number: K781089
·
Decision Jul 17, 1978
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
15
Applicant Total
18
Review Days
18
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Basic Information
- Device Name
- ONE INCISION BI-POLAR ELECTRO. FORCEPS
- K Number
- K781089
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4150
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Kli
- Date Received
- June 29, 1978
- Decision Date
- July 17, 1978
- Product Code
- HIN
- Advisory Committee
- Obstetrics/Gynecology
- 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 |
|---|---|---|---|
| HIN | Coagulator-Cutter, Endoscopic, Bipolar (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by Kli
| K Number | Device Name | ||
|---|---|---|---|
| K800822 | CO2 CYSTOSCOPY/URETHROSCOPY CONSOLE | Jun 17, 1980 | Substantially Equivalent |
| K800913 | GYNECOLOGICAL CYSTO/URETHROSCOPE | May 14, 1980 | Substantially Equivalent |
| K781913 | INSUFFALATOR LAPARAOSCOPIC | Dec 4, 1978 | Substantially Equivalent |
| K781109 | FORCEPS, ELECTROSURGICAL | Sep 14, 1978 | Substantially Equivalent |
| K780955 | SCISSORS, HOOK, ELECTROSURGICAL | Jun 22, 1978 | Substantially Equivalent |
| K780954 | SCISSORS, HOOK, ELECTROSURGICAL | Jun 22, 1978 | Substantially Equivalent |
| K772297 | INSUFFLATOR, MODEL G100 & 200 | Jan 5, 1978 | Substantially Equivalent |
| K772242 | LAPAROSCOPY CONSOLE MODEL VIII | Dec 20, 1977 | Substantially Equivalent |
| K772220 | PROBE, COAGULATION ACCESSORY | Dec 13, 1977 | Substantially Equivalent |
| K772185 | LAPAROSCOPE W/REMOVABLE OPTICS | Nov 30, 1977 | Substantially Equivalent |