GCY · Class I · 21 CFR 878.4680

FDA Product Code GCY: Apparatus, Suction, Single Patient Use, Portable, Nonpowered

Leading manufacturers include Pudenz-Schulte Medical Research Corp., Sherwood Medical Co. and Davol, Inc..

96
Total
96
Cleared
64d
Avg days
1976
Since

FDA 510(k) Cleared Apparatus, Suction, Single Patient Use, Portable, Nonpowered Devices (Product Code GCY)

96 devices
1–24 of 96
Cleared Oct 01, 1997
REDYROB-CLOSED WOUND DRAINAGE SYSTEM
K972703
B.Braun Medical, Inc.
General & Plastic Surgery · 75d
Cleared Jun 03, 1997
ODONTIT AUTOGENOUS BONE COLLECTION DEVICE
K971036
Interpore Intl.
General & Plastic Surgery · 75d
Cleared Dec 12, 1996
CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500
K963839
Cordis Corp.
General & Plastic Surgery · 79d
Cleared Mar 11, 1996
PENROSE DRAIN MODELS 6001 - 6007
K960099
Sil-Med Corp.
General & Plastic Surgery · 60d
Cleared Apr 25, 1995
MACRO SUCTION TUBE MODEL NO 10061
K950754
Dlp, Inc.
General & Plastic Surgery · 67d
Cleared May 12, 1994
PRESSURE IRRIGATING SYSTEM
K936223
Level 1 Technologies, Inc.
General & Plastic Surgery · 134d
Cleared Feb 22, 1994
AUTOVAC CLOSED WOUND SUCTION SYSTEM
K930615
Boehringer Laboratories
General & Plastic Surgery · 382d
Cleared Oct 27, 1993
BIRTCHER GS-9480 INTEGRATED 3-CHIP CAMERA/XENON LIGHT SOURCE VISUALIZATION SYSTEM
K933319
Birtcher Medical Systems, Inc.
General & Plastic Surgery · 112d
Cleared Oct 05, 1993
IMC 5.0MM IRRIGATION/ASPIRATION PROBE
K933305
Inman Medical Corp.
General & Plastic Surgery · 90d
Cleared Oct 05, 1993
IMC 5.0MM IRRIGATION/ASPIRATION PROBE W/HOLES
K933306
Inman Medical Corp.
General & Plastic Surgery · 90d
Cleared Sep 16, 1993
INMAN POOLE TIP SUCTION PROBE W/TUBING KIT
K933170
Inman Medical Corp.
General & Plastic Surgery · 79d
Cleared Aug 11, 1993
POOLE TIP SUCTION PROBE
K931950
Mayaguez Medical Center
General & Plastic Surgery · 113d
Cleared Aug 10, 1993
5.0 MM IRRIGATION/ASPIRATION PROBE
K931856
Mayaguez Medical Center
General & Plastic Surgery · 119d
Cleared May 21, 1993
ORC TAPPERED IRRIGATING PROBE
K925024
O.R. Concepts, Inc.
General & Plastic Surgery · 231d
Cleared May 17, 1993
# 9455 AND #9457 POOLE TIP SUCTION PROBE
K923908
O.R. Concepts, Inc.
General & Plastic Surgery · 286d
Cleared Mar 24, 1993
ABDOVAC (TM), BELLOVAC (TM) AND EXUDRAIN
K920819
Astra Meditec AB
General & Plastic Surgery · 394d
Cleared Feb 26, 1993
KENDALL TRU-CLOSE INFECTION CONTROL EVACUATOR
K925989
Kendall Healthcare Products Co. Div.Of Tyco Health
General & Plastic Surgery · 93d
Cleared Feb 01, 1993
KENDALL TRU-CLOSE(TM) SUCTION RESERVOIR, 150 ML
K925749
Kendall Healthcare Products Co. Div.Of Tyco Health
General & Plastic Surgery · 80d
Cleared Sep 15, 1992
J-VAC BULB SUCTION RESERVOIR
K922895
Johnson & Johnson Medical, Inc.
General & Plastic Surgery · 91d
Cleared Aug 14, 1992
SOLCOVAC WOUND DRAINAGE SYSTEM
K915867
Solco Basle, Inc.
General & Plastic Surgery · 227d
Cleared Mar 26, 1992
DAVOL 100CC SILICONE CLOSED WOUND DRAINAGE EVAC
K915536
Davol, Inc.
General & Plastic Surgery · 107d
Cleared Apr 15, 1991
MICROTEK-HERITAGES SILICONE BULB EVACUATION SYSTEM
K910167
Microbio-Medics, Inc.
General & Plastic Surgery · 90d
Cleared Jan 28, 1991
SEROMA-CATH CLOSE DRAINAGE SYSTEM
K905733
Dawn Medical
General & Plastic Surgery · 35d
Cleared May 07, 1990
INAMED SMALL DRAIN SYSTEM
K901742
Inamed Development Co.
General & Plastic Surgery · 20d

About Product Code GCY - Regulatory Context