510(k) K890215
- Device
- MICROSURGICAL SCARIFIER
- Applicant
- KINETIC MEDICAL PRODUCTS
- 510(k) number
- K890215
- Product code
- EMF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-01-27
- Date received
- 1989-01-18
- 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
- JAMES I LAUGHNER
- Address
- 4934 Peach St. Erie PA US 16509 16509
FDA Registration Numbers#
- 3014334038
- 3015895045
- 3036795921
- 8010374
- 3035708926
- 9613083
- 1820334
- 1220477
- 3004215117
- 3012366928
- 2032098
- 1421879
- 9613926
- 9681161
- 3042940336
- 1018470
- 8043507
- 2249529
- 9612086
- 9616250
- 3011499367
- 3003435550
- 8010099
- 3002834291
- 3018318562
- 3014268446
- 3009968482
- 3003418325
- 8043816
- 8010372
- 3005528784
- 3004450679
- 3044819802
- 3018821071
- 3010692967
- 1219313
- 2134752
- 3009340886
- 9612075
- 3003407244
- 3045855232
- 3021244152
- 9611503
- 3010123303
- 1421101
- 8040278
- 3008843439
- 1055890
- 3004598675
- 3027556548
- 3003431869
- 1043534
- 1720929
- 9610612
- 8043496
- 9616246
- 3010055973
- 2245304
- 9614062
- 3017352116
- 3008808049
- 3031231776
- 3005921503
- 3010202439
- 3010353847
- 3013784566
- 9680735
- 3008770252
- 3011625373
- 3006446479
- 1056350
- 1057946
- 9614069
- 9681622
- 3031564283
- 3011529314
- 3016112537
- 3015512299
- 2244478
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 |
| 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 |
| 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