FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
SURGISTEEL
K Number: K865038
·
Decision Jun 30, 1987
Classifications
1
FEI Numbers
74
Registration Numbers
74
Same Product Code
31
Applicant Total
11
Review Days
188
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Basic Information
- Device Name
- SURGISTEEL
- K Number
- K865038
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4495
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Sutures , Ltd.
- Date Received
- December 24, 1986
- Decision Date
- June 30, 1987
- Product Code
- GAQ
- 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 |
|---|---|---|---|
| GAQ | Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile | 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 |
| K943216 | SURGIDEK | Dec 5, 1994 | 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 |