510(k) K884862
- Device
- ANCHOR DOUBLE-EDGE MYRINGOTOMY BLADE
- Applicant
- ANCHOR PRODUCTS CO.
- 510(k) number
- K884862
- Product code
- GES
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-12-27
- Date received
- 1988-11-21
- 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
- ROBERT H THRUN
- Address
- 52 Official Rd. Addison IL US 60101 60101
FDA Registration Numbers#
- 3007389672
- 3004009671
- 3038718579
- 3005440795
- 2245304
- 3030447506
- 3023443842
- 1250045
- 3040389290
- 2523320
- 3004215117
- 9680794
- 3014649053
- 8010370
- 8031525
- 3015726551
- 2431166
- 2080222
- 1625425
- 1421879
- 3019356409
- 3009703496
- 1061124
- 1060680
- 3032391
- 3007334784
- 3016438694
- 3017910185
- 9680143
- 8040278
- 3007887711
- 3002090132
- 8010099
- 3010041511
- 3035678069
- 2438391
- 3006110126
- 3003477135
- 3009049852
- 3014615697
- 3018783415
- 9611579
- 2242450
- 8040263
- 1315756
- 9611283
- 3010131137
- 3019387954
- 3015173212
- 3012536737
- 3004111573
- 3007597038
- 3004993527
- 1054811
- 9680718
- 8010617
- 1724474
- 3033589330
- 3005787343
- 3013683058
- 3010055973
- 3003759558
- 3016844398
- 3000328994
- 2436986
- 3010123256
- 3010220595
- 3001124136
- 2320762
- 3003244954
- 1054241
- 8010159
- 3012507533
- 3015895045
- 3008496560
- 8031015
- 3008808049
- 3004176895
- 3005273623
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 |
| 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 |
| K863867 | DEXTRA DISPOSABLE BLADES | Storz Instrument Co. | 1986-10-24 |
| K863214 | KEISEI MICRO-BLADES (STERILE AND NON-STERILE) | Keisei Medical Industrial Co., Ltd. | 1986-09-02 |
| 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#
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