510(k) K863213
- Device
- KEISEI SCALPEL (STERILE AND NON-STERILE)
- Applicant
- KEISEI MEDICAL INDUSTRIAL CO., LTD.
- 510(k) number
- K863213
- Product code
- GDX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-09-02
- Date received
- 1986-08-20
- 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#
- Contact
- DEBORAH A KUTER
- Address
- 9 Autumn Dr. Bethel CT US 06801 06801
FDA Registration Numbers#
- 2182318
- 1423537
- 3006425876
- 3006128100
- 2029275
- 3013226
- 9610612
- 2031528
- 1216677
- 3014334038
- 3010966701
- 3004971305
- 3006897996
- 9616250
- 9610622
- 2431166
- 3010147274
- 3010934635
- 2648623
- 1052728
- 3004431266
- 3043615454
- 3010202439
- 2032112
- 9611194
- 3015895045
- 3011529314
- 3001650535
- 3004608878
- 1054241
- 1123010
- 3002808270
- 3010032115
- 3013188547
- 3011371465
- 9611959
- 1923569
- 3010220595
- 2649798
- 8040179
- 3015183635
- 3008812560
- 8040573
- 3010055973
- 1121142
- 1921846
- 1123137
- 1055236
- 3014649053
- 3003775395
- 3007597038
- 3016825318
- 3005853033
- 8010300
- 3013632692
- 2243072
- 3006210673
- 1221934
- 3015259874
- 2020550
- 3003661577
- 3004530184
- 3008489813
- 3009771213
- 3015859709
- 9614636
- 3005587147
- 3004859153
- 3004911384
- 9612030
- 3012187635
- 3043226252
- 3005273623
- 3013683058
- 3004050971
- 8040278
- 3013784566
- 3009732568
- 9680735
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 |
| 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 |
| K834541 | H.R. JAKOBI SURG. INSTRUMENTS #9-SEC.48 | Imm Enterprises , Ltd. | 1984-01-27 |
| K833467 | SURE-CUT | Diverse Technologies, Inc. | 1984-01-27 |
Legacy Summary#
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FDA Review#
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