FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE
K Number: K021019
·
Decision Jun 18, 2002
Classifications
1
FEI Numbers
242
Registration Numbers
242
Same Product Code
173
Applicant Total
27
Review Days
81
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
- COTTONY II, SILKY II POLYDEK & TEVDEK II POLYESTER SUTURE
- K Number
- K021019
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.5000
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Genzyme Corp.
- Date Received
- March 29, 2002
- Decision Date
- June 18, 2002
- 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 Genzyme Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K061508 | OSOM INFLUENZA A&B TEST | Jun 12, 2006 | Substantially Equivalent |
| K051244 | GENZYME OSOM INFLUENZA A & B TEST | Feb 21, 2006 | Substantially Equivalent |
| K040241 | N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET | Jun 25, 2004 | Substantially Equivalent |
| K040868 | SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH | Jun 4, 2004 | Substantially Equivalent |
| K033864 | GENZYME OSOM TRICHOMONAS RAPID TEST | Apr 2, 2004 | Substantially Equivalent |
| K023544 | GENZYME CONTRAST II HCG URINE/SERUM TEST | Jan 16, 2003 | Substantially Equivalent |
| K021316 | ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR | Jul 25, 2002 | Substantially Equivalent |
| K012532 | SEPRAGEL SINUS | Oct 30, 2001 | Substantially Equivalent |
| K011843 | GENZYME DIRECT-AMYLASE TEST REAGENT | Aug 10, 2001 | Substantially Equivalent |
| K000239 | GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL | Mar 21, 2000 | Substantially Equivalent |