510(k) K904218
- Device
- SUCTION SYSTEM
- Applicant
- AXIOM MEDICAL, INC.
- 510(k) number
- K904218
- Product code
- GEA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-10-31
- Date received
- 1990-09-12
- Regulation
- 878.4800
- Classification name
- Cannula, 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
- MAHENDRA SANGHVI
- Address
- 7625 Rosecrans Ave. Suite 29/ P.O. Box 1306 Paramount CA US 90723 90723
FDA Registration Numbers#
- 1221934
- 2431166
- 2029275
- 9611274
- 3012447612
- 3032747418
- 3011371465
- 3004638600
- 2182979
- 3024988980
- 1836161
- 1017768
- 2437731
- 9616250
- 3009998573
- 3009499159
- 3010052499
- 3012185136
- 3031564283
- 3004049923
- 9615126
- 2434839
- 9611827
- 3008902714
- 3022320321
- 3010405304
- 3030186176
- 3009417901
- 3008624479
- 3012358417
- 8040233
- 8010704
- 3005809810
- 3017567825
- 3006847937
- 2529846
- 9617429
- 1320894
- 1055236
- 3012724179
- 3007507973
- 3004705187
- 3010455030
- 9681161
- 3022132808
- 3016112537
- 3013557562
- 9611102
- 1423537
- 3008132398
- 3006108336
- 9611579
- 2183744
- 3005075853
- 8043971
- 1423662
- 3007773213
- 3010026090
- 9613926
- 2511556
- 3014615697
- 3006694268
- 3004976965
- 8043507
- 3009973505
- 3015399803
- 1000614268
- 1036836
- 2245304
- 3008559295
- 2953359
- 3031231776
- 2132732
- 9614062
- 3025603301
- 1424478
- 5906
- 3006517555
- 1061927
- 3008770252
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GEA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K003965 | MRI SAFE INSTRUMENTS | Aesculap, Inc. | 2001-03-16 |
| K982472 | GENICON TROCAR | Genicon, LC | 1999-02-04 |
| K954599 | CONMED TROGARD ELECTRONIC TROCAR SYSTEM | Conmedcorp | 1995-11-27 |
| K922460 | ORIGIN SECONDARY CANNULA AND TROCAR | Origin Medsystems, Inc. | 1992-09-16 |
| K920110 | ENDOPATH DISPOSABLE THORACIC TROCAR SLEEVE | ETHICON, Inc. | 1992-04-02 |
| K911262 | DISPOSABLE SPECIMEN BAG W/CANNULA AND INTRODUCER | ETHICON, Inc. | 1991-06-20 |
| K904881 | DISPOSABLE YANKAUER SUCTION TUBE | Pilling Medical S.A. | 1991-03-06 |
| K903416 | CANNULA, SURGICAL | Advantage Diagnostics Corp. | 1990-11-23 |
| K901717 | KLEIN MICRO-CANNULA(TM) | Jeff Klein Surgical, Inc. | 1990-05-24 |
| K901718 | KLEIN LAMPREY-CANNULA(TM) | Jeff Klein Surgical, Inc. | 1990-05-24 |
| K901719 | KLEIN MICRO-CANNULA HANDLE(TM) | Jeff Klein Surgical, Inc. | 1990-05-22 |
| K895684 | SOFT SUCTION ADAPTER | Applied Medical Technologies | 1989-11-20 |
| K896434 | AUTO SUTURE SURGIPORT CANNULA DIAMETER REDUCER* | United States Surgical, A Division of Tyco Healthc | 1989-11-16 |
| K895762 | CANULA SUCTION FOR SURGICAL GENERAL AND PLASTIC | Kolster Methods | 1989-10-18 |
| K895670 | SURGICAL SUCTION APPARATUS | Baker-Sundt Research, Inc. | 1989-09-27 |
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