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#
- 3015895045
- 2953359
- 3035708926
- 3011547624
- 3030446844
- 8043548
- 1820334
- 3004464325
- 1220477
- 3004215117
- 1421879
- 3012415195
- 3020954746
- 3008812251
- 9615005
- 1219518
- 9615765
- 9616250
- 3011499367
- 8010099
- 3009142291
- 8010877
- 3003418325
- 8010372
- 1926681
- 1221934
- 3005528784
- 3013756169
- 3021519357
- 3011024991
- 8043746
- 8010518
- 2424366
- 3033536312
- 1421101
- 8040278
- 2011171
- 3008843439
- 3004598675
- 3027556548
- 2085947
- 3003431869
- 3016994953
- 9610612
- 2245304
- 1319660
- 3012507533
- 3031231776
- 1450662
- 3009889060
- 3043355002
- 3008770252
- 5906
- 1056350
- 8020712
- 3008254127
- 2080222
- 8044057
- 3011600579
- 9681572
- 1211566
- 3006591312
- 2528981
- 3003807268
- 3005049530
- 1218017
- 3010237768
- 3009495876
- 3013247477
- 1835444
- 3011452218
- 9680242
- 3009255580
- 3007648354
- 3010462278
- 3034543751
- 2246552
- 1058726
- 9710524
- 3005067367
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 |