510(k) K800177
- Device
- I.M. BLADES
- Applicant
- INSTRUMENT MAKAR, INC.
- 510(k) number
- K800177
- Product code
- GDX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-02-11
- Date received
- 1980-01-28
- Regulation
- 878.4800
- Classification name
- Scalpel, One-piece
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3010934635
- 3022862651
- 3013557562
- 3008812560
- 3015183635
- 3015859709
- 2032112
- 3031481074
- 3004971305
- 1836546
- 3014680809
- 3005587147
- 2020550
- 9610612
- 9611283
- 3003418325
- 3009746061
- 2649798
- 9616250
- 1417592
- 3013226
- 3003694247
- 1055236
- 9612030
- 3013188547
- 1423537
- 8010300
- 3004050971
- 3004911384
- 2243072
- 3009771213
- 3010155661
- 9611680
- 3041915827
- 8040278
- 9611959
- 2183301
- 3014649053
- 3004431266
- 3006638824
- 2032098
- 2031093
- 3010621964
- 3004464325
- 1060680
- 3009560891
- 3013632692
- 3003316695
- 3026041755
- 9680889
- 9612278
- 2648623
- 2182318
- 3016659819
- 3011137372
- 3005273623
- 9612074
- 3005853033
- 3007185216
- 1836161
- 3003882387
- 3010220595
- 3014334038
- 1035907
- 3004530184
- 1526711
- 3010659131
- 1054241
- 2028661
- 3005675811
- 3043615454
- 8031020
- 9614636
- 3029082594
- 3011371465
- 2648727
- 3003431869
- 9680794
- 3001650535
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GDX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K923689 | SURGISTAR BLADES | Surgistar, Inc. | 1992-09-09 |
| K921167 | ULTRABLADE | Micron Technology, Inc. | 1992-07-30 |
| K914086 | ICAN CYLINDRICAL SPONGES | Icn Pharmaceuticals, Inc. | 1991-10-09 |
| K904505 | CCI CORNEAL SCARIFIER | Buckman Co., Inc. | 1991-04-23 |
| K905380 | 1-CUT ACL GRAFT KNIFE | Depuy, Inc. | 1990-12-13 |
| K895682 | VESSEL LOOPS | Applied Medical Technologies | 1989-10-24 |
| K893033 | MINI-DIAMOND KNIFE | L.A.B. Instruments | 1989-05-26 |
| K880028 | OMED DISPOSABLE SCALPEL | Oxboro Medical Intl., Inc. | 1988-01-29 |
| K871894 | KCK INDUSTRIES' SURGICAL INSTRUMENTS | Kck Industries | 1987-06-23 |
| K863950 | P.S.I.-DISPOSABLE METAL HANDLE SURGEONS SCALPEL | Precision Surgical Industries, Inc. | 1986-10-24 |
| K863213 | KEISEI SCALPEL (STERILE AND NON-STERILE) | Keisei Medical Industrial Co., Ltd. | 1986-09-02 |
| K854857 | SCALPEL, ONE-PIECE, DISPOSABLE | Medelec Intl. Corp. | 1985-12-24 |
| K853103 | MCKNIFE | Medical Dimensions | 1985-08-06 |
| K851751 | 7-120, 7-130,7-140, 7-150,9-151 TO 168, 9-171 TO 1 | Artiberia | 1985-06-20 |
| K833467 | SURE-CUT | Diverse Technologies, Inc. | 1984-01-27 |
Legacy Summary#
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FDA Review#
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