510(k) K863549
- Device
- REUSABLE/DISPOSABLE AUTOPSY KNIFE SET
- Applicant
- SURGIPATH MEDICAL INDUSTRIES, INC.
- 510(k) number
- K863549
- Product code
- EMF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-09-30
- Date received
- 1986-09-12
- 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
- URBAN, HT(ASCP)
- Address
- P.O. Box 769 Grayslake IL US 60030 60030
FDA Registration Numbers#
- 9614069
- 3022862651
- 3018821071
- 9611461
- 3013497507
- 8040233
- 3011164188
- 8044098
- 3003334541
- 3016965929
- 2020550
- 1313525
- 2020601
- 3035678069
- 1720747
- 3003418325
- 3012226300
- 3004450679
- 9610612
- 9611283
- 3006059835
- 3007773213
- 3008770252
- 3008843439
- 9610905
- 2248180
- 1056350
- 1720929
- 3004135030
- 8010298
- 3003956316
- 3004450489
- 8040263
- 3001297506
- 9616250
- 1417592
- 3042940336
- 1043534
- 3005440795
- 3002769835
- 9611274
- 3005031160
- 3004193466
- 9613079
- 1646747
- 9616246
- 2242450
- 3010155661
- 3014268446
- 8043467
- 8040278
- 9680515
- 2437731
- 8010732
- 9615857
- 3023155873
- 2032098
- 1057946
- 3004552850
- 9680002
- 3010399422
- 3015972835
- 3044819802
- 8040881
- 3025376090
- 9612278
- 3009703496
- 8010890
- 3036795921
- 1066959
- 2126670
- 9680718
- 3013846070
- 3005180920
- 3004598675
- 3009513193
- 3012267976
- 3007123908
- 3002834291
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 |
| 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 |
| K843497 | SURGICAL KNIVES & PROBES | Eder Instrument Co, Inc. | 1984-10-31 |
| 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