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#
- 2528981
- 9610612
- 9680837
- 1219518
- 3013756169
- 3034669683
- 1211566
- 1835444
- 3021519357
- 3006591312
- 3010437008
- 9616250
- 8043746
- 2431166
- 3009142291
- 3010131578
- 3009255580
- 3016248634
- 8044098
- 3005067367
- 3011547624
- 1047843
- 3018094310
- 2011171
- 3008843439
- 1421101
- 3015895045
- 3004608878
- 1054241
- 3003597504
- 2245304
- 3043620689
- 9611278
- 1320468
- 3010470577
- 3004001706
- 3011706110
- 3016994953
- 9680242
- 8010372
- 3006154292
- 9611102
- 1219930
- 5906
- 9710524
- 1220477
- 3005049530
- 1923569
- 3003761012
- 3008812560
- 1058726
- 1287329
- 8020712
- 3015209038
- 9611112
- 9610773
- 1422634
- 1055236
- 2085947
- 3007597038
- 3009956343
- 3012415195
- 1720747
- 3033536312
- 3035708926
- 3008797953
- 2424366
- 8043548
- 2031917
- 3007589150
- 2953359
- 8030607
- 2126670
- 2084346
- 1221934
- 3041277555
- 3009513193
- 3016096142
- 3004530184
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 |