Product Code: GEA
FDA class 1
21 CFR 878.4800
Cannula, Surgical, General & Plastic Surgery
General, Plastic Surgery
The Cannula, Surgical, General and Plastic Surgery (product code GEA) is a hollow tube inserted into a body cavity, vessel, or tissue to allow drainage, access, or infusion during general or plastic surgery procedures, serving as a conduit for instruments or fluids. It is classified as FDA Class 1, the lowest risk tier, requiring only general controls and no premarket notification. The device is regulated under 21 CFR 878.4800 in the General, Plastic Surgery specialty (SU). No special flags apply to this device.
510(k)s
36
FEI Numbers
375
Registration Numbers
375
Unique Applicants
30
Years Active
20
Basic Information
- Product Code
- GEA
- Device Class
- FDA class 1
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 36 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K003965 | MRI SAFE INSTRUMENTS | Mar 16, 2001 | Substantially Equivalent | AESCULAP, INC. |
| K982472 | GENICON TROCAR | Feb 04, 1999 | Substantially Equivalent | GENICON, LC |
| K954599 | CONMED TROGARD ELECTRONIC TROCAR SYSTEM | Nov 27, 1995 | Substantially Equivalent | CONMED CORP. |
| K922460 | ORIGIN SECONDARY CANNULA AND TROCAR | Sep 16, 1992 | Substantially Equivalent | ORIGIN MEDSYSTEMS, INC. |
| K920110 | ENDOPATH DISPOSABLE THORACIC TROCAR SLEEVE | Apr 02, 1992 | Substantially Equivalent | ETHICON, INC. |
| K911262 | DISPOSABLE SPECIMEN BAG W/CANNULA AND INTRODUCER | Jun 20, 1991 | Substantially Equivalent | ETHICON, INC. |
| K904881 | DISPOSABLE YANKAUER SUCTION TUBE | Mar 06, 1991 | Substantially Equivalent | PILLING MEDICAL S.A. |
| K903416 | CANNULA, SURGICAL | Nov 23, 1990 | Substantially Equivalent | ADVANTAGE DIAGNOSTICS CORP |
| K904218 | SUCTION SYSTEM | Oct 31, 1990 | Substantially Equivalent | AXIOM MEDICAL, INC. |
| K901718 | KLEIN LAMPREY-CANNULA(TM) | May 24, 1990 | Substantially Equivalent | JEFF KLEIN SURGICAL, INC. |
| K901717 | KLEIN MICRO-CANNULA(TM) | May 24, 1990 | Substantially Equivalent | JEFF KLEIN SURGICAL, INC. |
| K901719 | KLEIN MICRO-CANNULA HANDLE(TM) | May 22, 1990 | Substantially Equivalent | JEFF KLEIN SURGICAL, INC. |
| K895684 | SOFT SUCTION ADAPTER | Nov 20, 1989 | Substantially Equivalent | APPLIED MEDICAL TECHNOLOGIES |
| K896434 | AUTO SUTURE SURGIPORT CANNULA DIAMETER REDUCER* | Nov 16, 1989 | Substantially Equivalent | UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC |
| K895762 | CANULA SUCTION FOR SURGICAL GENERAL AND PLASTIC | Oct 18, 1989 | Substantially Equivalent | KOLSTER METHODS |
| K895670 | SURGICAL SUCTION APPARATUS | Sep 27, 1989 | Substantially Equivalent | BAKER-SUNDT RESEARCH, INC. |
| K880669 | L-5 PLASTIC SURGERY CANNULAS | Mar 17, 1988 | Substantially Equivalent | AMERICAN INSTRUMENT MANUFACTURER'S, INC. |
| K872214 | COOPER SURG ASPIRATION CANNULA/CUSTOM CONVEN PAKS | Aug 17, 1987 | Substantially Equivalent | COOPERVISION, INC. |
| K872906 | SUCTION TUBE TIP FITS OVER BUSSIE FRAZIER TUBE | Aug 11, 1987 | Substantially Equivalent | AMERICAN SILK SUTURES, INC. |
| K871384 | APEX SUCTION CURETTE | May 22, 1987 | Substantially Equivalent | APEX MEDICAL, INC. |
| K871043 | (I) LV AND (II) HV SERIES CANNULA | Apr 23, 1987 | Substantially Equivalent for Some Indications | CELEBRATION MEDICAL PRODUCTS, INC. |
| K863293 | DISPOSABLE SUCTION CANNULA NO. 902008-000 | Sep 09, 1986 | Substantially Equivalent | LIFESTREAM INT'L, INC. |
| K863150 | BOWEN CANNULA | Sep 05, 1986 | Substantially Equivalent | BOWEN & COMPANY, INC. |
| K862936 | NEWMAN CANNULAE SYSTEM (NCS) | Aug 14, 1986 | Substantially Equivalent for Some Indications | BYRON MEDICAL |
| K861306 | SUCTION SYSTEM | Jun 09, 1986 | Substantially Equivalent | AXIOM MEDICAL, INC. |
| K854005 | DEDO SUCTION CANNULA | Dec 06, 1985 | Substantially Equivalent for Some Indications | DEDO MANUFACTURER, INC. |
| K844874 | PENNINE LINK YANKAUERS | Jun 06, 1985 | Substantially Equivalent | PENNINE MEDICAL LTD. |
| K843468 | PHARMA-PLAST SUCTION SET TYPE YANKAUER | Nov 23, 1984 | Substantially Equivalent | ZIMMAR CONSULTING LTD. |
| K843187 | CANNULA | Oct 31, 1984 | Substantially Equivalent | ETHICON, INC. |
| K833377 | MEDICALEX | Sep 27, 1984 | Substantially Equivalent | MEDICALEX |
| K841249 | SUCTION CANNULAS | Jun 04, 1984 | Substantially Equivalent | CUSTOM SURGICAL PRODUCTS, INC. |
| K833717 | PADGETT SUCTION CANNULA | Dec 14, 1983 | Substantially Equivalent | ADVANCED BIOSEARCH ASSN. |
| K832521 | PLASTIC SUCTION TIPS | Oct 20, 1983 | Substantially Equivalent | WELLS JOHNSON CO. |
| K832520 | SUCTION TIPS | Oct 20, 1983 | Substantially Equivalent | WELLS JOHNSON CO. |
| K832636 | FRAZIER SUCTION INSTRUMENT-DISPOS | Oct 14, 1983 | Substantially Equivalent | PILLING CO. |
| K810627 | MODEL 1301 BIOTAC (TM) | Apr 02, 1981 | Substantially Equivalent | PROGRESS MANKIND TECHNOLOGY |
FEI Numbers
This FDA classification entry is associated with 375 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 375 registration numbers. Click on an entry to view related FDA registrations.