510(k) K895762
- Device
- CANULA SUCTION FOR SURGICAL GENERAL AND PLASTIC
- Applicant
- KOLSTER METHODS
- 510(k) number
- K895762
- Product code
- GEA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-10-18
- Date received
- 1989-09-26
- 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
- ALWIN KOLSTER
- Address
- 1895 W. Commonwealth Ave. Unit 'G' Fullerton CA US 92633 92633
FDA Registration Numbers#
- 3010611926
- 2084346
- 1320468
- 3023191945
- 3004638600
- 3015859709
- 3019696820
- 3014615697
- 8010099
- 3009732568
- 1522875
- 3015877656
- 9681161
- 3006517555
- 9615005
- 3009161688
- 9612030
- 3016467822
- 3007366790
- 3005641619
- 1017294
- 3030444864
- 3003334541
- 3011600579
- 1649518
- 3033589330
- 3008785630
- 3003597504
- 8010273
- 9610612
- 8043971
- 3003759558
- 3008770707
- 3011371465
- 3006108336
- 3008559295
- 3013840437
- 8040278
- 3007895168
- 2132732
- 2183650
- 1222773
- 2431166
- 3013557562
- 3010097171
- 3006611221
- 3007597038
- 9680741
- 1226544
- 3003604053
- 1000517406
- 9680794
- 2086043
- 1836161
- 3004638532
- 3022568093
- 2183744
- 3013846070
- 3009973505
- 2024022
- 3005809810
- 9611283
- 3011137372
- 1833053
- 9680518
- 3033536312
- 8010372
- 3012536737
- 3004705187
- 8010343
- 3038195984
- 3029082594
- 3013438730
- 1219602
- 3014342096
- 3038356900
- 3012494290
- 3010026090
- 2183456
- 8043554
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 |
| 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 |
| K895670 | SURGICAL SUCTION APPARATUS | Baker-Sundt Research, Inc. | 1989-09-27 |
Legacy Summary#
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FDA Review#
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