FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
POLYVIOLENE(TM) SUTURE
K Number: K904054
·
Decision Oct 3, 1990
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
16
Applicant Total
25
Review Days
64
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Basic Information
- Device Name
- POLYVIOLENE(TM) SUTURE
- K Number
- K904054
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5000
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Look, Inc.
- Date Received
- July 31, 1990
- Decision Date
- October 3, 1990
- Product Code
- GAS
- 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 |
|---|---|---|---|
| GAS | Suture, Nonabsorbable, Synthetic, Polyester | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GAS), ordered by most recent decision date.
RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture
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RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD SUTURE, 2-0 Polypropylene
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ARTHREX BIOWIRE
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MR-III
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SUTURE CORD
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BRAIDED POLYESTER SUTURE MATERIAL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Look, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K943949 | POLYVIOLENE SURGICL SUTURE | Nov 10, 1994 | Substantially Equivalent for Some Indications |
| K933686 | LOOK INC. 316L STAINLESS STEEL SURGICAL SUTURE | Dec 23, 1993 | Substantially Equivalent |
| K926586 | REVISED LABELING FOR CHROMIC AND PLAIN GUT SUTURES | Dec 22, 1993 | Substantially Equivalent |
| K926587 | REVISED LABELING FOR NYLON SUTURE (POLYAMIDE) | Dec 17, 1993 | Substantially Equivalent |
| K926167 | POLYVIOLENE SUTURE-REVISED LABELING | Dec 17, 1993 | Substantially Equivalent |
| K926588 | REVISED LABELING FOR POLYPROPYLENE SUTURE | Dec 17, 1993 | Substantially Equivalent |
| K926168 | SILK SUTURES-REVISED LABELING | Dec 17, 1993 | Substantially Equivalent |
| K913530 | LOOK VISCODISSECTOR | Oct 21, 1991 | Substantially Equivalent |
| K903029 | STERILE BLACK MONOFILAMENT NYLON NON-ABSOR. SUTURE | Oct 25, 1990 | Substantially Equivalent |
| K903584 | POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES | Oct 11, 1990 | Substantially Equivalent |