FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇬🇧 United Kingdom
SURGIDEK
K Number: K943216
·
Decision Dec 5, 1994
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
56
Applicant Total
11
Review Days
153
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Basic Information
- Device Name
- SURGIDEK
- K Number
- K943216
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5020
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Sutures , Ltd.
- Date Received
- July 5, 1994
- Decision Date
- December 5, 1994
- Product Code
- GAR
- 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 |
|---|---|---|---|
| GAR | Suture, Nonabsorbable, Synthetic, Polyamide | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Sutures , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K990432 | SURGISORB | May 27, 1999 | Substantially Equivalent for Some Indications |
| K953609 | PRODEK | Jan 31, 1996 | Substantially Equivalent for Some Indications |
| K943222 | SURGIDEK S | Dec 5, 1994 | Substantially Equivalent for Some Indications |
| K943218 | CHROMIC CATGUT | Dec 5, 1994 | Substantially Equivalent for Some Indications |
| K943223 | SURGIDEK B | Dec 5, 1994 | Substantially Equivalent for Some Indications |
| K943221 | SURGIBOND | Dec 5, 1994 | Substantially Equivalent for Some Indications |
| K943217 | PLAIN CATGUT | Dec 5, 1994 | Substantially Equivalent for Some Indications |
| K943627 | SURGISILK | Dec 5, 1994 | Substantially Equivalent for Some Indications |
| K943220 | SUTULENE | Dec 5, 1994 | Substantially Equivalent for Some Indications |
| K865038 | SURGISTEEL | Jun 30, 1987 | Substantially Equivalent |