COATED SUTURE NEEDLE
FDA 510(k) clearance K863595 · decided 1986-10-24
Clearance details
- K-number
- K863595
- Device name
- COATED SUTURE NEEDLE
- Applicant
- Sharpoint, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-09-15
- Decision date
- 1986-10-24
- Days to decision
- 39 days
- Clearance type
- Traditional
- Product code
- GAB
- Device class
- 1
- Regulation number
- 878.4800
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Reading, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DIGICAP (K012199) | Humana USA, Inc. | 2001-12-19 |
| AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS) (K980988) | Axya Medical, Inc. | 1998-05-11 |
| ENDO-JUDGE (K932591) | Synergistic Medical Technologies, Inc. | 1993-12-22 |
| CONTRAST BACKGROUND MATERIAL (K895681) | Applied Medical Technologies | 1989-10-24 |
| ANCHOR BRAND SURGICAL NEEDLES (K831648) | Anchor Products Co. | 1983-08-16 |
| RADIATION STERILIZATION FOR NEEDLE CNTR (K812444) | Devon Industries, Inc. | 1981-12-14 |
| SCANLAN STERNUM NEEDLE-SUTURE (K801976) | Scanlan Intl., Inc. | 1980-09-26 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SILK SURGICAL SUTURES (N85143/S004) | Sharpoint, Inc. | 1988-08-31 |
| SILK SURGICAL SUTURES (N85143/S007) | Sharpoint, Inc. | 1988-07-19 |
| SILK SURGICAL SUTURES (N85143/S006) | Sharpoint, Inc. | 1988-03-22 |
| SILK SURGICAL SUTURES (N85143/S005) | Sharpoint, Inc. | 1987-10-13 |
| SUTURES (N85143/S003) | Sharpoint, Inc. | 1987-08-27 |
| SUTURES (N85143/S002) | Sharpoint, Inc. | 1987-04-03 |
| SUTURES (N85143/S001) | Sharpoint, Inc. | 1986-10-27 |