510(k) K931379
- Device
- Microvasive Insurg Laptie Suture Ligator
- Applicant
- BOSTON SCIENTIFIC CORP.
- 510(k) number
- K931379
- Product code
- HCF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-07-13
- Date received
- 1993-03-18
- Regulation
- 878.4800
- Classification name
- Instrument, Ligature Passing And Knot Tying
- Medical specialty
- General, Plastic Surgery
- Review panel
- General, Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- STEPHEN M PAGE
- Address
- 2710 Orchard Pkwy. San Jose CA US 95134 95134
FDA Registration Numbers#
- 3008280196
- 2529846
- 3007589150
- 3003761012
- 3030446844
- 3011024991
- 3006154292
- 1923569
- 3007773213
- 3004608878
- 3041277555
- 3009889060
- 9616250
- 3005440795
- 8044057
- 1926681
- 3010178296
- 2011171
- 2431166
- 3032747418
- 3010687973
- 3006591312
- 3003807268
- 3035708926
- 3004001706
- 3005067367
- 3011137372
- 3003431869
- 8010518
- 3010437008
- 2916714
- 3001620590
- 1219518
- 1043214
- 3012267976
- 3009142291
- 9610773
- 1319660
- 3008812251
- 2085947
- 3008254127
- 3009255580
- 3023657851
- 3012185136
- 9611112
- 3010041511
- 3009513193
- 3013756169
- 3030839824
- 2031768
- 8043746
- 8040233
- 3011706110
- 1211566
- 2246552
- 8010877
- 3007137643
- 1054241
- 1720747
- 1721676
- 3008114965
- 9611283
- 3010383847
- 3011499367
- 1058726
- 3016994953
- 1219930
- 3027556548
- 1422634
- 1055236
- 9710524
- 3007544634
- 3010462278
- 1320468
- 3018094310
- 1218017
- 9681572
- 3034543751
- 3005049530
- 1412854
Source Documents#
Other 510(k) Records For Product Code HCF#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K150882 | Edwards Suture Fastening System | Edwards Lifesciences, LLC | 2015-06-16 |
| K851452 | VALTRAC PURSESTING DEVICE | Davis & Geck, Inc. | 1985-06-12 |
| K841617 | STROVER HOOK | Plastafil, Inc. | 1984-08-27 |
| K790577 | HEMORRHOIDAL LIGATOR | J. Sklar Mfg. Co., Inc. | 1979-04-23 |