510(k) K915119
- Device
- SCALPEL BLADE REMOVER (BLADEGARD)
- Applicant
- INTERGRATED VISUAL, INC.
- 510(k) number
- K915119
- Product code
- GES
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-05-05
- Date received
- 1991-11-13
- Regulation
- 878.4800
- Classification name
- Blade, Scalpel
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICHARD K.HESS
- Address
- Boatmen"S Bank Buiding 6th & Hampshire Suite 609 Quincy IL US 62301 62301
FDA Registration Numbers#
- 3003244954
- 3003965134
- 3003775395
- 3004450489
- 1416666
- 9680411
- 3032953138
- 3009578786
- 3043648115
- 3004859153
- 3010583458
- 3004111573
- 3043226252
- 3033589330
- 3009703496
- 9611503
- 3008936260
- 2530138
- 3002090132
- 3032391
- 3007791573
- 3004417597
- 2242450
- 3011659880
- 1828288
- 3003537565
- 3049552730
- 2410251
- 3008247695
- 3014615697
- 1036836
- 3012507533
- 3002808270
- 3014815360
- 3005595283
- 3008496560
- 1035907
- 3009746061
- 3015309643
- 3009560891
- 3043615454
- 3029901632
- 2438391
- 1043214
- 3044819802
- 3013683058
- 1644312
- 3008388005
- 1646747
- 1423537
- 3010220595
- 1220905
- 3008489813
- 1724474
- 1054241
- 1424263
- 9611680
- 1421879
- 3040389290
- 3010115803
- 8010704
- 8010329
- 3003032798
- 3003807268
- 3014383302
- 9680927
- 3012494290
- 3009495876
- 3010692967
- 3030019171
- 8010732
- 3010303097
- 2649798
- 9610612
- 9680890
- 3008392711
- 3012002722
- 3035678069
- 3006110126
- 3010864832
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 |
| 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 |
| 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#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases