510(k) K863867
- Device
- DEXTRA DISPOSABLE BLADES
- Applicant
- STORZ INSTRUMENT CO.
- 510(k) number
- K863867
- Product code
- GES
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-10-24
- Date received
- 1986-10-03
- 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
- DAN REGAN
- Address
- 3365 Tree Ct. Industrial Blvd. St. Louis MO US 63122 63122
FDA Registration Numbers#
- 3007887711
- 3014314985
- 3022862651
- 3004571672
- 1250045
- 3013557562
- 3004468256
- 3004971305
- 3043648115
- 1649395
- 3016844398
- 3035678069
- 1119522
- 3006110126
- 3003418325
- 9610612
- 3008388005
- 3002714597
- 3010303097
- 9611283
- 3008770252
- 3009746061
- 9610905
- 2649798
- 8031015
- 1724474
- 1720929
- 3004135030
- 1643817
- 3003537565
- 8010298
- 3004450489
- 8040263
- 1066741
- 9616250
- 1417592
- 3012507533
- 1055236
- 3005787343
- 3005440795
- 3040389290
- 1423537
- 3002858762
- 3004993527
- 3004082121
- 9613079
- 3021477808
- 1032347
- 2243072
- 1646747
- 2242450
- 3003032798
- 9611680
- 3014815360
- 3003477135
- 8040278
- 9611959
- 3033526648
- 2183301
- 3014649053
- 3016032497
- 8010732
- 9614157
- 3004605321
- 2032098
- 9680222
- 1057946
- 3010621964
- 1424263
- 3009560891
- 9611367
- 1060680
- 3026041755
- 3044819802
- 3016674858
- 3010123256
- 3014683120
- 1721504
- 3009889060
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 |
| 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