INSORB ABSORBABLE STAPLE, MODEL SP-B20
FDA 510(k) clearance K033602 · decided 2003-12-16
Clearance details
- K-number
- K033602
- Device name
- INSORB ABSORBABLE STAPLE, MODEL SP-B20
- Applicant
- Incisive Surgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-11-14
- Decision date
- 2003-12-16
- Days to decision
- 32 days
- Clearance type
- Special
- Product code
- GDW
- Device class
- 2
- Regulation number
- 878.4750
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Plymouth, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Insorb Subcuticular Skin Stapler. INSORB staples are made from an absorbable copolymer whi recall (Z-1545-2015) | Incisive Surgical Inc | 2015-04-29 |