FDA Product Code
FDA Product Code GAB — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4800
510(k) Clearances — 8 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K012199 | DIGICAP | Humana USA, Inc. | 2001-12-19 | Traditional | PDF ↗ |
| K980988 | AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS) | Axya Medical, Inc. | 1998-05-11 | Traditional | PDF ↗ |
| K932591 | ENDO-JUDGE | Synergistic Medical Technologies, Inc. | 1993-12-22 | Traditional | PDF ↗ |
| K895681 | CONTRAST BACKGROUND MATERIAL | Applied Medical Technologies | 1989-10-24 | Traditional | PDF ↗ |
| K863595 | COATED SUTURE NEEDLE | Sharpoint, Inc. | 1986-10-24 | Traditional | PDF ↗ |
| K831648 | ANCHOR BRAND SURGICAL NEEDLES | Anchor Products Co. | 1983-08-16 | Traditional | PDF ↗ |
| K812444 | RADIATION STERILIZATION FOR NEEDLE CNTR | Devon Industries, Inc. | 1981-12-14 | Traditional | PDF ↗ |
| K801976 | SCANLAN STERNUM NEEDLE-SUTURE | Scanlan Intl., Inc. | 1980-09-26 | Traditional | PDF ↗ |
Product code GAB · Class I · General, Plastic Surgery. Data: openFDA.