510(k) K863808
- Device
- THE S. CORDERO STYLUS
- Applicant
- S. CORDERO CO.
- 510(k) number
- K863808
- Product code
- GDZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-10-14
- Date received
- 1986-09-30
- Regulation
- 878.4800
- Classification name
- Handle, Scalpel
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- SERGIO S CORDERO
- Address
- 2da Cerrada De Camelia # 30 Col. Florida Mexico City Cp 01030 MX
FDA Registration Numbers#
- 3011767135
- 2031528
- 2084346
- 8043752
- 2320762
- 3023191945
- 3044819802
- 3013421458
- 3006487092
- 3014615697
- 8010099
- 3002769835
- 3004892425
- 9680620
- 3013938829
- 1522875
- 3001146947
- 9681161
- 3015416207
- 2183301
- 3019404837
- 9616088
- 3010303097
- 3016825318
- 3005641619
- 3014649053
- 3013273457
- 3003334541
- 3011600579
- 1123010
- 3016894896
- 3009051471
- 3010583458
- 3003597504
- 8010273
- 3013156185
- 9610612
- 3003759558
- 3010621964
- 9615659
- 2243072
- 2134947
- 3011371465
- 8032033
- 3005897698
- 3003644849
- 8010300
- 3009578786
- 8040278
- 2132732
- 2431166
- 3013557562
- 3010097171
- 8043368
- 2648727
- 3015876273
- 1123137
- 3007597038
- 3043047788
- 1226544
- 3003604053
- 9680563
- 3002808270
- 9680794
- 3036795921
- 3009973336
- 1836161
- 9613083
- 3013846070
- 3006082533
- 3005809810
- 9611283
- 3011137372
- 3003038445
- 3008048818
- 9614157
- 8040884
- 3002807115
- 9680518
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GDZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K091462 | SPECTRA MEDICAL SAFETY SCAPEL | Spectra, Inc. | 2009-12-15 |
| K890242 | SCALPEL HANDLE | Kinetic Medical Products | 1989-01-27 |
| K884512 | BEAVER(R) HANDLE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-11-17 |
| K863951 | P.S.I.-DISPOSABLE SCALPEL SURGEONS HANDLE | Precision Surgical Industries, Inc. | 1986-10-24 |
| K863212 | KEISEI HANDLES FOR SURGICAL BLADES | Keisei Medical Industrial Co., Ltd. | 1986-09-02 |
| K854858 | SCALPEL HANDLE | Medelec Intl. Corp. | 1985-12-24 |
| K852711 | SCALPEL HANDLE #3 SS 410 OR 420 | The Huxley Instrument Corp. | 1985-07-15 |
| K852735 | SCALPEL HANDLE #7 SS 410 OR 420 | The Huxley Instrument Corp. | 1985-07-15 |
| K851750 | 7-103, 7-104, 7-107 SCALPEL HANDLES, #3 #4 #7 | Artiberia | 1985-06-20 |
| K852042 | BRIMFIELD CANNULATED BLADE HOLDER | Brimfield Scientific Instruments | 1985-06-11 |
| K812876 | SURGICAL PAWS | M-W Laboratories, Inc. | 1981-11-20 |
| K812814 | ZEE SURGICAL INSTRUMENTS | Zee Medical Products Co., Inc. | 1981-11-06 |
| K812070 | BORES* ADJUSTABLE BLADE HOLDER | Santa Barbara Medco, Inc. | 1981-08-18 |
| K810720 | I.M. SCALPEL HANDLE | Instrument Makar, Inc. | 1981-04-03 |
| K761035 | SURGICAL BLADE HANDLES | Parke-Davis Co. | 1976-12-21 |
Legacy Summary#
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FDA Review#
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