FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
1-125 ENDOSEED
K Number: K914825
·
Decision Mar 19, 1992
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
150
Applicant Total
10
Review Days
143
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Basic Information
- Device Name
- 1-125 ENDOSEED
- K Number
- K914825
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5730
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Endo Technic Corp.
- Date Received
- October 28, 1991
- Decision Date
- March 19, 1992
- Product Code
- KXK
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| KXK | Source, Brachytherapy, Radionuclide | FDA class 2 | Radiology |
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Other Clearances by Endo Technic Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K990908 | MILLENNIUM | May 27, 1999 | Substantially Equivalent |
| K971459 | DERMALASE | Jul 18, 1997 | Substantially Equivalent |
| K925079 | LAPAROSCOPIC INST. (SCISSORS,FORCEPS,NEEDLEHOLDER) | Aug 24, 1994 | Substantially Equivalent |
| K930756 | LAPAROSCOPIC IRRIGATION/ASPIRATION HANDPIECE | Mar 9, 1994 | Substantially Equivalent |
| K925114 | LAPAROSCOPIC INSTRUMENTS | Feb 28, 1994 | Substantially Equivalent |
| K924058 | TROCAR | Mar 30, 1993 | Substantially Equivalent |
| K910200 | LASER-35 | May 9, 1991 | Substantially Equivalent |
| K864976 | SOLUSET CALCIUM DEMINERALIZING SOLUTION | Feb 27, 1987 | Substantially Equivalent |
| K862129 | SET CANAL SEALER PASTE | Jul 22, 1986 | Substantially Equivalent |