FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇬🇧 United Kingdom
SUTULENE
K Number: K943220
·
Decision Dec 5, 1994
Classifications
1
FEI Numbers
242
Registration Numbers
242
Same Product Code
173
Applicant Total
11
Review Days
153
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
- SUTULENE
- K Number
- K943220
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5000
- 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
- GAT
- 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 |
|---|---|---|---|
| GAT | Suture, Nonabsorbable, Synthetic, Polyethylene | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GAT), ordered by most recent decision date.
Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HyperSuture All Green Extension Line
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Meniscus Versaflex
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Pre-Sutured Tendon
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ProZip Knotless Implant
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PowerKnot High Strength Sutures
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
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 |
| K865038 | SURGISTEEL | Jun 30, 1987 | Substantially Equivalent |