FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SILICONE SUMP DRAIN
K Number: K862767
·
Decision Aug 7, 1986
Classifications
1
FEI Numbers
40
Registration Numbers
40
Same Product Code
26
Applicant Total
29
Review Days
16
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Basic Information
- Device Name
- SILICONE SUMP DRAIN
- K Number
- K862767
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4200
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Sil-Med Corp.
- Date Received
- July 22, 1986
- Decision Date
- August 7, 1986
- Product Code
- GBS
- 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 |
|---|---|---|---|
| GBS | Catheter, Ventricular, General & Plastic Surgery | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GBS), ordered by most recent decision date.
ATRIUMS PDR THORACIC CATHETER
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AXIOM ATRAUM WOUND DRAINS
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·General, Plastic Surgery
INTRODUCTION/DRAINAGE CATHETER & ACCESS
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URESIL WOUND DRAIN TROCAR
FDA 510(k)
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·General, Plastic Surgery
NOVO VIVO SUCTION CATHETER VESSEL W/MUCOSE TRAP
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CLOSED CHEST DRAINAGE SET W/SUTURES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
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 |
| K960099 | PENROSE DRAIN MODELS 6001 - 6007 | Mar 11, 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 |