GCY · Class I · 21 CFR 878.4680

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

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

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 Feb 22, 1994
AUTOVAC CLOSED WOUND SUCTION SYSTEM
K930615
Boehringer Laboratories
General & Plastic Surgery · 382d
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 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 Mar 26, 1992
DAVOL 100CC SILICONE CLOSED WOUND DRAINAGE EVAC
K915536
Davol, Inc.
General & Plastic Surgery · 107d
Cleared Dec 27, 1989
CLOSED WOUND RESERVOIR
K896803
Westmark, Sterile Packing Systems, Inc. (Sps)
General & Plastic Surgery · 26d
Cleared Oct 18, 1988
CLOSED WOUND SUCTION DEVICE
K883472
Westmark, Sterile Packing Systems, Inc. (Sps)
General & Plastic Surgery · 63d
Cleared Sep 02, 1988
AMBU TWIN PUMP - (MANUAL SUCTION PUMP)
K883433
Ambu, Inc.
General & Plastic Surgery · 18d
Cleared Feb 24, 1988
HEYER-SCHULTE(R) 100CC & 400CC EXUDATE DISP. BAGS
K880650
Baxter Healthcare Corp
General & Plastic Surgery · 7d
Cleared Sep 08, 1987
MAXIVAC(TM) CLOSED WOUND SUCTION DRAINAGE SYSTEM
K873332
American V. Mueller
General & Plastic Surgery · 20d
Cleared Oct 14, 1986
DRAINOVAC COMPLETE CLOSED WOUND DRAINAGE DEVICE
K863482
Cardio Metrics, Inc.
General & Plastic Surgery · 35d
Cleared Sep 29, 1986
URESIL 150CC BELLOWS RESERVOIR
K863562
Uresil Corp.
General & Plastic Surgery · 17d
Cleared Sep 18, 1986
URESIL CLOSED DRAINAGE RESERVOIR
K863505
Uresil Corp.
General & Plastic Surgery · 9d
Cleared Aug 29, 1986
NEW USE FOR ACUVAC SUCTION RESERVOIR 400CC
K863201
Allergan, Inc.
General & Plastic Surgery · 10d
Cleared Nov 20, 1985
BARD PARKER 150CC BELLOWS RESERVOIR
K854424
Bd Becton Dickinson Vacutainer Systems Preanalytic
General & Plastic Surgery · 15d
Cleared Jun 04, 1985
ECONOMY 400 CWS WITH PVC DRAINS
K851084
C.R. Bard, Inc.
General & Plastic Surgery · 78d
Cleared Oct 31, 1984
CONCEPT C-VAC
K842710
Concept, Inc.
General & Plastic Surgery · 111d

About Product Code GCY - Regulatory Context