510(k) K080133
- Device
- MOUNTABLE ENDOSCOPIC BLADE
- Applicant
- A.M. SURGICAL, INC.
- 510(k) number
- K080133
- Product code
- EMF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-03-13
- Date received
- 2008-01-18
- Regulation
- 878.4800
- Classification name
- Knife, Surgical
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- VINCENT PASCALE
- Address
- 290 E. Main St. Suite 200 Smithtown NY US 11787 11787
FDA Registration Numbers#
- 3011164188
- 3014334038
- 2529846
- 3007589150
- 1043534
- 1923569
- 3008902714
- 3009703496
- 3004705187
- 3001644167
- 3006142527
- 3007773213
- 3004608878
- 1057946
- 8010159
- 8010890
- 3007143290
- 9616246
- 3031564283
- 9616250
- 3005440795
- 3004552850
- 3005180920
- 3006059835
- 2431166
- 3006446479
- 2434839
- 3032747418
- 3011625373
- 3003807268
- 3005049358
- 3013497507
- 3035708926
- 3016069968
- 1058584
- 3005067367
- 3011137372
- 3003431869
- 3002769835
- 8043816
- 8010257
- 3004450489
- 2916714
- 3012366928
- 3015177648
- 2248180
- 3002834291
- 1066959
- 3042034415
- 1055890
- 3012267976
- 3010834934
- 3006561161
- 3010692967
- 3017352116
- 3002090132
- 3012185136
- 1932180
- 9611112
- 1219313
- 9680518
- 3010041511
- 2032098
- 3003435550
- 3009513193
- 3029901632
- 3013846070
- 3018318562
- 8040233
- 1833506
- 3003334541
- 3044819802
- 2028661
- 3010353847
- 9680002
- 1018470
- 9680735
- 3007137643
- 3029082594
Source Documents#
Other 510(k) Records For Product Code EMF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| 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#
summary
FDA Review#
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