510(k) K863214
- Device
- KEISEI MICRO-BLADES (STERILE AND NON-STERILE)
- Applicant
- KEISEI MEDICAL INDUSTRIAL CO., LTD.
- 510(k) number
- K863214
- Product code
- GES
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-09-02
- Date received
- 1986-08-20
- Regulation
- 878.4800
- Classification name
- Blade, Scalpel
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DEBORAH A KUTER
- Address
- 9 Autumn Dr. Bethel CT US 06801 06801
FDA Registration Numbers#
- 1123010
- 1724474
- 3008388005
- 3014334038
- 3030019171
- 2530138
- 1424263
- 2529846
- 3012421607
- 3010220595
- 3030446844
- 9680411
- 3009049852
- 3009703496
- 3016844398
- 3004705187
- 3003644849
- 8022032
- 3004608878
- 1057946
- 2183650
- 1825034
- 9613910
- 9680794
- 3045058049
- 8010159
- 3009889060
- 1119522
- 8043441
- 3031564283
- 9616250
- 3004111573
- 3005440795
- 3012536737
- 2183301
- 3019356409
- 1416666
- 3007389672
- 3013466775
- 3008247695
- 2431166
- 3007887711
- 3008912461
- 1522875
- 3016170492
- 3003807268
- 3043226252
- 9616088
- 3014683120
- 3035708926
- 3007478714
- 9680222
- 3004468256
- 1054811
- 1058584
- 3005067367
- 3011137372
- 8010329
- 8010257
- 3004001706
- 3004450489
- 1420054
- 3009578786
- 1066741
- 8010697
- 8010370
- 2916714
- 3012366928
- 8022890
- 3010032115
- 3015177648
- 1043214
- 3004571672
- 3000268902
- 3003759558
- 3017910185
- 9611194
- 3010692967
- 3017367014
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GES #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K032242 | PERSONNA PLUS SAFETY SCALPEL SYSTEM | Omi Manufacturing Pty., Ltd. | 2003-09-23 |
| K932998 | EASY-ON | Devon Industries, Inc. | 1993-08-18 |
| K923170 | LOS ALAMOS RETRACTABLE KNIFE | Innovative Surgical Technology, Inc. | 1993-02-18 |
| K915119 | SCALPEL BLADE REMOVER (BLADEGARD) | Intergrated Visual, Inc. | 1992-05-05 |
| K911913 | PRECISION GLIDE - ENHANCED SURGICAL BLADE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-05-13 |
| K900266 | STERILE CARBON STEEL SURGICAL BLADE | Rahn Laboratories | 1990-03-01 |
| K884862 | ANCHOR DOUBLE-EDGE MYRINGOTOMY BLADE | Anchor Products Co. | 1988-12-27 |
| K881638 | SURGICAL BLADE | Far East Intl. Trading Corp. | 1988-06-15 |
| K880244 | SURGICAL BLADES | Ailee C/O Havel'S, Inc. | 1988-02-10 |
| K873493 | NINJA SCALPEL | Primrose Medical, Inc. | 1987-09-24 |
| K873142 | PERSONNA DISPOSABLE SCALPEL | American Safety Razor Co. | 1987-09-04 |
| K863867 | DEXTRA DISPOSABLE BLADES | Storz Instrument Co. | 1986-10-24 |
| K863885 | SABLE BLADES | Sable Industries | 1986-10-24 |
| K863211 | KEISEI SURGICAL BLADES (STERILE & NON-STERILE) | Keisei Medical Industrial Co., Ltd. | 1986-09-02 |
| K855104 | ANGIOMED SKIN FASCIA KNIFE | Angiomed U.S., Inc. | 1986-01-24 |
Legacy Summary#
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FDA Review#
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