510(k) K914086
- Device
- ICAN CYLINDRICAL SPONGES
- Applicant
- ICN PHARMACEUTICALS, INC.
- 510(k) number
- K914086
- Product code
- GDX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-10-09
- Date received
- 1991-09-11
- Regulation
- 878.4800
- Classification name
- Scalpel, One-piece
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- STEPHEN J GOLDNER
- Address
- Icn Plz. 3300 Hyland Ave. Costa Mesa CA US 92626 92626
FDA Registration Numbers#
- 3008812251
- 3010041511
- 8040573
- 9616250
- 3026041755
- 2020550
- 3004464325
- 3003661577
- 3023191945
- 8040179
- 3013188547
- 3009746061
- 3013683058
- 3004971305
- 3004911384
- 1000604079
- 1221934
- 1423662
- 9610622
- 2182318
- 3006425876
- 1123137
- 3003807268
- 3010202439
- 1921846
- 3010155661
- 9611194
- 9612074
- 3001650535
- 3005595283
- 9680889
- 3010220595
- 1423537
- 3006897996
- 3017352116
- 3006410968
- 3008102042
- 3029901632
- 2243072
- 3011623994
- 3010659131
- 3005675811
- 9680794
- 1722447
- 3003418325
- 3003431869
- 3015895045
- 3005273623
- 3026844237
- 3011600579
- 3010147274
- 3013632692
- 3030733800
- 1058584
- 3004125670
- 2649798
- 3043615454
- 3015183635
- 3015859709
- 2031093
- 3048101437
- 8010300
- 1043214
- 3006210673
- 3002862271
- 2032098
- 3004431266
- 2029275
- 9611283
- 2648623
- 3003316695
- 3007389672
- 2529846
- 3002808270
- 1123010
- 2031528
- 3009560891
- 3011529314
- 9611024
- 3016659819
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 |
| 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 |
| K834541 | H.R. JAKOBI SURG. INSTRUMENTS #9-SEC.48 | Imm Enterprises , Ltd. | 1984-01-27 |
Legacy Summary#
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FDA Review#
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