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#
- 3004749705
- 3021519357
- 3045058049
- 3042235752
- 1526534
- 3043355002
- 3005809810
- 3005641619
- 3007024186
- 2183449
- 3015451162
- 9613079
- 8043769
- 3010202439
- 3015877656
- 9611112
- 3014579161
- 3008114965
- 3015289316
- 9610617
- 3005405146
- 3009513193
- 1054811
- 1060680
- 1721504
- 9611610
- 3043226252
- 3013011598
- 3023155873
- 3013503739
- 2511556
- 3006847937
- 8010343
- 3013909820
- 3029082594
- 3013438730
- 3007366790
- 9615005
- 1055236
- 3011680766
- 3029754081
- 9617429
- 1030489
- 3003587189
- 9681387
- 3009039068
- 1649660
- 3022568093
- 3012494290
- 3015859709
- 3017406274
- 9680741
- 9681161
- 3004001706
- 3005418651
- 8043385
- 3036756245
- 8010099
- 3017567825
- 3003828812
- 1531174
- 3008110533
- 3013784566
- 3011191255
- 3005182241
- 1423537
- 2133928
- 5906
- 2183425
- 2183570
- 3019585045
- 3014840003
- 2029275
- 3005448067
- 1526439
- 8043548
- 3034688516
- 1921846
- 9710649
- 3007791599
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 |
| K901718 | KLEIN LAMPREY-CANNULA(TM) | Jeff Klein Surgical, Inc. | 1990-05-24 |
| K901717 | KLEIN MICRO-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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