510(k) K843497
- Device
- SURGICAL KNIVES & PROBES
- Applicant
- EDER INSTRUMENT CO, INC.
- 510(k) number
- K843497
- Product code
- EMF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-10-31
- Date received
- 1984-09-06
- Regulation
- 878.4800
- Classification name
- Knife, Surgical
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DANIEL D FETTERLEY
- Address
- 735 N. Water St. Suite 1102 Milwaukee, Wi 53202 US 53202 53202
FDA Registration Numbers#
- 9611503
- 1222773
- 8010298
- 9710524
- 3007773213
- 9610905
- 8040881
- 3016112537
- 1416605
- 2529846
- 3002808270
- 3014334038
- 9611283
- 3011529314
- 3012995405
- 3006142527
- 3011164188
- 3002769835
- 9680735
- 3011499367
- 3042034415
- 3003418325
- 9611278
- 3008808049
- 3011625373
- 1422507
- 9615857
- 2431166
- 3004598675
- 9614986
- 9614062
- 3035678069
- 1649518
- 3009968482
- 3010353847
- 1833506
- 3012267976
- 3039414397
- 3013784566
- 3015895045
- 2919128
- 2249529
- 3045855232
- 1932180
- 3009703496
- 3016965929
- 3008902714
- 3003334541
- 3036795921
- 3007137643
- 8010159
- 9611461
- 9680518
- 1018470
- 3004450679
- 3007123908
- 9680002
- 2084346
- 8010257
- 8010273
- 1057946
- 3005067367
- 3002834291
- 8010732
- 3001297506
- 1646747
- 1066959
- 3005049358
- 3009768364
- 9616250
- 3010123303
- 9612278
- 9680515
- 2032098
- 3000286616
- 3019404837
- 3018821071
- 2436906
- 2916714
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EMF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K080133 | MOUNTABLE ENDOSCOPIC BLADE | A.M. Surgical, Inc. | 2008-03-13 |
| K982142 | MOUNTABLE ENDOSCOPIC KNIFE | A.M. Surgical, Inc. | 1998-12-30 |
| K890214 | MICROSURGERY RAZOR BLADE HOLDER | Kinetic Medical Products | 1989-01-27 |
| K890215 | MICROSURGICAL SCARIFIER | Kinetic Medical Products | 1989-01-27 |
| K890217 | MICROSURGICAL KNIVES | Kinetic Medical Products | 1989-01-27 |
| K880094 | VAN-TEC ENDOPYELOTOMY KNIFE | Van-Tec, Inc. | 1988-02-29 |
| K863752 | VALTRAC (BAR) REMOVER DEVICE | Davis & Geck, Inc. | 1986-10-24 |
| K863549 | REUSABLE/DISPOSABLE AUTOPSY KNIFE SET | Surgipath Medical Industries, Inc. | 1986-09-30 |
| K861947 | SURGICAL KNIFE | Sharpoint, Inc. | 1986-06-06 |
| K854891 | KNIFE | Euro-Med Intl. | 1986-05-02 |
| K851784 | 27-210 PLASTER KNIFE (REINER) | Artiberia | 1985-06-20 |
| K843371 | VALVOTOMY KNIFE | Downs Surgical , Ltd. | 1984-10-25 |
| K834184 | H.R. JAKOBI SURG. INSTRUMENTS #11 38/67 | Imm Enterprises , Ltd. | 1984-01-27 |
| K834197 | JAKOBI SURG. INSTR- #11 38/39/45/46/67 | Imm Enterprises , Ltd. | 1984-01-27 |
| K832368 | CHANGING METHOD OF STERILITY RELEASE | Devon Industries, Inc. | 1983-10-31 |
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