FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FORCE 1C
K Number: K921222
·
Decision Sep 23, 1992
Classifications
1
FEI Numbers
66
Registration Numbers
66
Same Product Code
52
Applicant Total
94
Review Days
194
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Basic Information
- Device Name
- FORCE 1C
- K Number
- K921222
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4120
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Valleylab, Inc.
- Date Received
- March 13, 1992
- Decision Date
- September 23, 1992
- Product Code
- HGI
- 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 |
|---|---|---|---|
| HGI | Electrocautery, Gynecologic (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by Valleylab, Inc.
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|---|---|---|---|
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| K010010 | VALLEYLAB LIGASURE PRECISE INSTRUMENT VESSEL SEALING SYSTEM-MODEL # LS1200 & SLIGAURE GENERATOR | Apr 2, 2001 | Substantially Equivalent |
| K010013 | LIGASURE LAPAROSCOPIC SEALER DIVIDER MODEL LS1100 | Mar 26, 2001 | Substantially Equivalent |
| K994428 | E7512 PREMIE REM POLYHESIVE II PATIENT RETURN ELECTRODE | Mar 7, 2000 | Substantially Equivalent |
| K983743 | BISURE LAPAROSCOPIC BIPOLAR FORCEPS | Jan 21, 1999 | Substantially Equivalent |
| K981916 | LIGASURE VESSEL SEALING SYSTEM | Aug 28, 1998 | Substantially Equivalent |
| K981262 | CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM | Jul 6, 1998 | Substantially Equivalent |
| K980915 | VALLEYLAB OPTIMUMM SMOKE EVACUATOR SYSTEM | Jun 29, 1998 | Substantially Equivalent |
| K970140 | E0520-TRIGGER SWITCH AND CORD/E0521-TRIGGER SWITCH | Mar 28, 1997 | Substantially Equivalent |
| K964636 | FORCE ARGON II ARGON ENHANCED ELECTROSURGICAL SYSTEM | Mar 11, 1997 | Substantially Equivalent |