FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
E1070 & E1080 SERIES REUSABLE LLETZ ELECTRODES
K Number: K921885
·
Decision Mar 25, 1994
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
0
Applicant Total
94
Review Days
703
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Basic Information
- Device Name
- E1070 & E1080 SERIES REUSABLE LLETZ ELECTRODES
- K Number
- K921885
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5390
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Valleylab, Inc.
- Date Received
- April 21, 1992
- Decision Date
- March 25, 1994
- Product Code
- HGZ
- 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 |
|---|---|---|---|
| HGZ | Heater, Perineal, Direct Contact | FDA class 2 | Obstetrics/Gynecology |
Other Clearances by Valleylab, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K031011 | LIGASURE 5MM LAPAROSCOPIC SEALER-DIVIDER, MODEL LS1500 | May 29, 2003 | Substantially Equivalent |
| 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 |