BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE
FDA 510(k) clearance K992088 · decided 1999-09-03
Clearance details
- K-number
- K992088
- Device name
- BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE
- Applicant
- Genzyme Surgical Product (Genzyme Biosurgery)
- Decision
- Substantially Equivalent
- Date received
- 1999-06-21
- Decision date
- 1999-09-03
- Days to decision
- 74 days
- Clearance type
- Traditional
- Product code
- GAM
- Device class
- 2
- Regulation number
- 878.4493
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Fall River, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Dekna-lok, 1 x 17.78 cm, Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorba recall (Z-1535-2014) | Teleflex Medical | 2014-05-01 |
| Various Sizes of Sterile Polygycolic Acid Synthetic Surgical Suture- Bondek, TOPS ASSY P/P recall (Z-1011-2007) | Teleflex Creek Dr | 2007-07-17 |
| Various Sizes of Sterile Polygycolic Acid Synthetic Surgical Suture: Bondek, BON GN BR 0 G recall (Z-1012-2007) | Teleflex Creek Dr | 2007-07-17 |
| Various Sizes of Sterile Polygycolic Acid Synthetic Surgical Suture--Bondek, BON+ VI BR 3- recall (Z-1013-2007) | Teleflex Creek Dr | 2007-07-17 |
| Various Sizes of Sterile Polygycolic Acid Synthetic Surgical Sutures -Bondek, BON+ BG BR 1 recall (Z-1014-2007) | Teleflex Creek Dr | 2007-07-17 |
| Various Sizes of Sterile Polyglycolic Acid Synthetic Surgical Suture-NDR, POLYGLY 2-0 C-2/ recall (Z-1019-2007) | Teleflex Creek Dr | 2007-07-17 |