510(k) K903416
- Device
- CANNULA, SURGICAL
- Applicant
- ADVANTAGE DIAGNOSTICS CORP
- 510(k) number
- K903416
- Product code
- GEA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-11-23
- Date received
- 1990-07-30
- 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
- DANIEL P MISENHIMER
- Address
- P.O. Box 12428 Tucson AZ US 85732 85732
FDA Registration Numbers#
- 3013247477
- 1720747
- 1226544
- 8010273
- 9680411
- 2029015
- 3003828812
- 8043496
- 3024988980
- 3016248634
- 3030979014
- 3017717188
- 3031231776
- 3043226252
- 3014656668
- 3010455030
- 3033589330
- 3044026004
- 2183425
- 3004957622
- 3010071016
- 3008936260
- 2434839
- 3036756245
- 3034676720
- 8040233
- 3009499159
- 3008624479
- 3033536312
- 3016112537
- 3004361445
- 8043816
- 3014615697
- 9681161
- 1036836
- 3023191945
- 1421101
- 3003687489
- 3015309643
- 3043051314
- 3005809810
- 1043214
- 3018544165
- 3010405304
- 3008110533
- 3013909820
- 3008034554
- 1424478
- 1412854
- 3031240334
- 1833053
- 3011302692
- 1219602
- 3007895168
- 1646747
- 1423537
- 1526439
- 2437731
- 3005528784
- 3008627763
- 2511556
- 1221763
- 3029754081
- 3001408183
- 9680518
- 2029275
- 3003604053
- 3001297506
- 3010687973
- 1056350
- 1054241
- 1424263
- 3010026090
- 3014579161
- 1421879
- 3008785630
- 9680515
- 2020550
- 3014437893
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 |
| K904218 | SUCTION SYSTEM | Axiom Medical, Inc. | 1990-10-31 |
| 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#
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FDA Review#
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