510(k) K012199
- Device
- DIGICAP
- Applicant
- Humana USA, Inc.
- 510(k) number
- K012199
- Product code
- GAB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-12-19
- Date received
- 2001-07-13
- Regulation
- 878.4800
- Classification name
- Needle, Suturing, Disposable
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- H.N. DUNNING
- Address
- 8309 Bryant Dr. Bethesda MD US 20817 20817
FDA Registration Numbers#
- 1123137
- 3007663056
- 3005440795
- 9680794
- 3014004349
- 1060680
- 9612030
- 8040278
- 3010041511
- 3002497459
- 3010131137
- 3015173212
- 3007597038
- 1226544
- 3004519921
- 9680258
- 3011585752
- 1313525
- 3010220595
- 1221934
- 3010039400
- 1054241
- 1000604079
- 3005273623
- 3006638824
- 3016851379
- 3010900528
- 1226146
- 2031093
- 3014527910
- 3010175289
- 1928237
- 1836161
- 3007344957
- 3008247695
- 3027977504
- 2183785
- 1526439
- 3016678045
- 3011299238
- 1043214
- 1219930
- 3015330458
- 3006108336
- 3014314985
- 3010331645
- 3003418325
- 1649390
- 3004859153
- 2530138
- 3004365956
- 1921846
- 1000112137
- 3005012805
- 1058584
- 3006210673
- 3020468145
- 1055236
- 3001650535
- 1825034
- 3004983210
- 1417592
- 3015209038
- 3008392711
- 3012470322
- 3008114965
- 3015151147
- 1529233
- 2029275
- 3004911384
- 3006554788
- 1423537
- 3012341425
- 3019269298
- 1017294
- 3024856795
- 3008912461
- 3010380518
- 1216677
Source Documents#
Other 510(k) Records For Product Code GAB#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K980988 | AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS) | Axya Medical, Inc. | 1998-05-11 |
| K932591 | ENDO-JUDGE | Synergistic Medical Technologies, Inc. | 1993-12-22 |
| K895681 | CONTRAST BACKGROUND MATERIAL | Applied Medical Technologies | 1989-10-24 |
| K863595 | COATED SUTURE NEEDLE | Sharpoint, Inc. | 1986-10-24 |
| K831648 | ANCHOR BRAND SURGICAL NEEDLES | Anchor Products Co. | 1983-08-16 |
| K812444 | RADIATION STERILIZATION FOR NEEDLE CNTR | Devon Industries, Inc. | 1981-12-14 |
| K801976 | SCANLAN STERNUM NEEDLE-SUTURE | Scanlan Intl., Inc. | 1980-09-26 |