510(k) K873493
- Device
- NINJA SCALPEL
- Applicant
- PRIMROSE MEDICAL, INC.
- 510(k) number
- K873493
- Product code
- GES
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-09-24
- Date received
- 1987-08-31
- 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
- FLETCHER LONGLEY
- Address
- 20 Cabot Rd. Woburn MA US 01801 01801
FDA Registration Numbers#
- 9680794
- 3002858762
- 3015276580
- 9616250
- 3030446844
- 3015225571
- 3010553238
- 2436986
- 1526534
- 3001124136
- 9611503
- 3004571672
- 3011547157
- 3013846070
- 3002090132
- 3043226252
- 3015140199
- 1051526
- 3004111573
- 3043615454
- 3009560891
- 3009513193
- 1416666
- 9614636
- 9680889
- 1828288
- 2438391
- 1724474
- 3010032115
- 3009968482
- 1421879
- 1450662
- 3031564283
- 1422507
- 3010055973
- 3002808145
- 9680927
- 9610612
- 8010159
- 9612086
- 3013557562
- 3006389770
- 1211998
- 3004371426
- 3003244954
- 3008912461
- 3033589330
- 3007496191
- 1424263
- 3021023132
- 9613910
- 3015173212
- 1720929
- 3009889060
- 3009578786
- 1054811
- 1036836
- 3008936260
- 3038718579
- 3010692967
- 3003807268
- 3013901429
- 3004135030
- 1721504
- 3043533459
- 2242450
- 3011137372
- 9680143
- 3015726551
- 3009703496
- 2416465
- 2523320
- 3014383302
- 9614157
- 3006897996
- 8010617
- 9615162
- 3011642792
- 3014815360
- 3007597038
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 |
| 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 |
| K863214 | KEISEI MICRO-BLADES (STERILE AND 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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