FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NAVIGATOR (STYLET) 2006
K Number: K972521
·
Decision Oct 1, 1997
Classifications
1
FEI Numbers
97
Registration Numbers
97
Same Product Code
6
Applicant Total
29
Review Days
86
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- NAVIGATOR (STYLET) 2006
- K Number
- K972521
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sil-Med Corp.
- Date Received
- July 7, 1997
- Decision Date
- October 1, 1997
- Product Code
- GAH
- 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 |
|---|---|---|---|
| GAH | Stylet, Surgical, General & Plastic Surgery | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GAH), ordered by most recent decision date.
VENX REVOLUTION
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ARACHNOPHLEBECTOMY NEEDLE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MARKMAN TEMPLATE SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
RAPID FIRE HAIR IMPLANTER CAROUSEL
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
CALVITRON HAIR TRANSPLANT SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
HAIR TRANSPLANT PUNCH, MULTIPLH
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by Sil-Med Corp.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K921424 | SIL-MED FLAT SUCTION DRAIN | Sep 28, 1992 | Substantially Equivalent |