FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PENROSE DRAIN MODELS 6001 - 6007
K Number: K960099
·
Decision Mar 11, 1996
Classifications
1
FEI Numbers
213
Registration Numbers
213
Same Product Code
95
Applicant Total
29
Review Days
60
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Basic Information
- Device Name
- PENROSE DRAIN MODELS 6001 - 6007
- K Number
- K960099
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4680
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sil-Med Corp.
- Date Received
- January 11, 1996
- Decision Date
- March 11, 1996
- Product Code
- GCY
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Sil-Med Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K972521 | NAVIGATOR (STYLET) 2006 | Oct 1, 1997 | Substantially Equivalent |
| K961392 | ANTIMICROBIAL PERITONEAL DIALYSIS COIL CATHETER WITH SPI-ARGENT II | Jul 18, 1997 | Substantially Equivalent |
| K961194 | ANTIMICROBIAL MEDIASTINAL SILICONE DRAIN | Aug 8, 1996 | Substantially Equivalent |
| K961295 | SAPPHIRE LINE FLAT DRAIN/KIT WITH SPI-ARGENT II W/OR W/OUT TROCAR | Jun 26, 1996 | Substantially Equivalent |
| K955463 | GRIP-A-BOOTS | Jan 23, 1996 | Substantially Equivalent |
| K942709 | MEDIASTINAL SILICONE DRAINS | Jan 4, 1996 | Substantially Equivalent for Some Indications |
| K926496 | SIL-SLIP (COATED/REGULAR(NON-COATED)THORACIC DRAIN | May 24, 1995 | Substantially Equivalent |
| K926408 | SIL-SLIP FLAT SUCTION DRAIN | Feb 2, 1994 | Substantially Equivalent |
| K926495 | SIL-SLIP ROUND WOUND DRAIN (COATED)/BLUE STRIPE | Feb 2, 1994 | Substantially Equivalent |
| K921424 | SIL-MED FLAT SUCTION DRAIN | Sep 28, 1992 | Substantially Equivalent |