FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE
K Number: K991191
·
Decision Jun 22, 1999
Classifications
1
FEI Numbers
140
Registration Numbers
140
Same Product Code
147
Applicant Total
9
Review Days
75
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Basic Information
- Device Name
- BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE
- K Number
- K991191
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4493
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Genzyme Surgical Product (Genzyme Biosurgery)
- Date Received
- April 8, 1999
- Decision Date
- June 22, 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 Genzyme Surgical Product (Genzyme Biosurgery)
| K Number | Device Name | ||
|---|---|---|---|
| K001440 | NEXTSTITCH CARDIOVASCULAR VALVE SUTURE | Nov 13, 2000 | Substantially Equivalent |
| K001434 | 'COTTONY' II DACRON, SILKY II POLYDEK & TEVDEK II POLYESTER NONABSORBABLE SURGICAL SUTURE | Jun 12, 2000 | Substantially Equivalent for Some Indications |
| K992088 | BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE | Sep 3, 1999 | Substantially Equivalent |
| K991416 | ENDOSCOPIC CAMERA | Jul 20, 1999 | Substantially Equivalent |
| K990062 | SAPHLIFT | Mar 30, 1999 | Substantially Equivalent |
| K982712 | RAPID TRANSFER BLOOD BAG MODEL A-1650, RAPID TRANSFER BLOOD BAG MODEL S-250 | Dec 18, 1998 | Substantially Equivalent |
| K980016 | MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE | Aug 7, 1998 | Substantially Equivalent |
| K981322 | CUTALON NYLON POLYAMIDE SURGICAL SUTURE | Jul 7, 1998 | Substantially Equivalent |