FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇬🇧 United Kingdom
SURGISORB
K Number: K990432
·
Decision May 27, 1999
Classifications
1
FEI Numbers
140
Registration Numbers
140
Same Product Code
147
Applicant Total
11
Review Days
105
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Basic Information
- Device Name
- SURGISORB
- K Number
- K990432
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4493
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Sutures , Ltd.
- Date Received
- February 11, 1999
- Decision Date
- May 27, 1999
- Product Code
- GAM
- 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 |
|---|---|---|---|
| GAM | Suture, Absorbable, Synthetic, Polyglycolic Acid | FDA class 2 | General, Plastic Surgery |
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Other Clearances by Sutures , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K865038 | SURGISTEEL | Jun 30, 1987 | Substantially Equivalent |