FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENDOMED LAPAROSCOPY INSTRUMENTS
K Number: K921686
·
Decision Mar 30, 1994
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
43
Applicant Total
111
Review Days
721
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Basic Information
- Device Name
- ENDOMED LAPAROSCOPY INSTRUMENTS
- K Number
- K921686
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4160
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Buckman Co., Inc.
- Date Received
- April 8, 1992
- Decision Date
- March 30, 1994
- Product Code
- KNF
- 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 |
|---|---|---|---|
| KNF | Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by Buckman Co., Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K961320 | CROSS MEDICAL BONE PLATE SYSTEM/ CM BONE PLATE SYSTEM/CROSS TI BONE PLATE SYSTEM | Jun 25, 1998 | Substantially Equivalent |
| K974641 | FUTURELASE 3000/3002 ERBIUM LASER SYSTEM | Jun 8, 1998 | Substantially Equivalent |
| K964252 | ORTHOCHUCK | May 27, 1997 | Substantially Equivalent |
| K950099 | SYNERGY(TM) TI POSTERIOR SPINAL SYSTEM | Jan 16, 1997 | Substantially Equivalent for Some Indications |
| K960451 | WEBB-MORLEY SPINE SYSTEM | Apr 18, 1996 | Substantially Equivalent for Some Indications |
| K950999 | KSF POSTERIOR SPINGAL FIXATOR FOR SEVERE SPONDYLOLISTHESIS | Jan 25, 1996 | Substantially Equivalent |
| K945756 | IMAGN(TM) 2000 SYSTEM | Dec 19, 1995 | Substantially Equivalent |
| K940003 | VOLUMET CD4 + AND CD8 + T LYMPHOCYTE COUNT TEST KIT | Oct 19, 1995 | Substantially Equivalent |
| K951117 | LIHTAN 532 LASER | Oct 18, 1995 | Substantially Equivalent |
| K942751 | VANGUARD SERIES GAS REGULATORS | Feb 9, 1995 | Substantially Equivalent |