510(k) K903419
- Device
- MODIFIED SURGIPORT DISPOSABLE TROCAR AND SLEEVE
- Applicant
- UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
- 510(k) number
- K903419
- Product code
- GDH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-08-09
- Date received
- 1990-07-31
- Regulation
- 878.4800
- Classification name
- Gouge, Surgical, General & Plastic Surgery
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- STEVE REITZLER
- Address
- 150 Glover Ave. Norwalk CT US 06856 06856
FDA Registration Numbers#
- 3007597038
- 3034676720
- 3005528784
- 3004168759
- 9616250
- 9610905
- 9611274
- 3036795921
- 3001297506
- 3002769835
- 3011371465
- 3005440795
- 3033536312
- 3015512299
- 3008936260
- 3004608878
- 3007648354
- 1219930
- 3012995405
- 1038671
- 5906
- 9611262
- 3014967149
- 9680519
- 2529846
- 9613083
- 3011683674
- 1923569
- 3005809810
- 2087382
- 3010829427
- 8010372
- 3011164188
- 8043507
- 9610612
- 3018094310
- 8010099
- 3003431869
- 3003694247
- 9680002
- 8030607
- 3031564283
- 1032347
- 3004598675
- 3011137372
- 3003407244
- 1818910
- 3019455
- 2436906
- 1932180
- 1926681
- 9680026
- 3005067367
- 3004892425
- 2248030
- 3009380063
- 3019404837
- 9710524
- 3005813597
- 9680837
- 3015516266
- 2431166
- 1219655
- 2647580
- 9611278
- 8040263
- 3004001706
- 3029082594
- 1219518
- 1222188
- 3010041511
- 1018470
- 9616671
- 3009255580
- 3022862651
- 3013055499
- 2249529
- 9612501
- 8010547
- 3002090132
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GDH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K900487 | MODIFIED AUTO SUTURE SURGIPORT TROCAR & SLEEVE | United States Surgical, A Division of Tyco Healthc | 1990-02-09 |
| K891901 | GOUGES, ALEXANDER, BISHOP, LUCAS | Zinnanti Surgical Instruments, Inc. | 1989-04-12 |
| K874879 | AUTO SUTURE(R) SURGIPORT DISPOS SURG TROCAR/SLEEVE | United States Surgical, A Division of Tyco Healthc | 1987-12-17 |
| K842822 | CHERMEL BONE GOUGES | Cher Mel Corp. | 1984-08-02 |
| K760850 | PARKES HUMP GAUGE STRAIGHT 7 (18 CM) | V. Mueller O.V. Baxter Healthcare Corp. | 1976-11-03 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases