GCY · Apparatus, Suction, Single Patient Use, Portable, Nonpowered
General, Plastic Surgery · 21 CFR 878.4680 · Class 1
Overview
| Product Code | GCY |
|---|---|
| Device Name | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| Regulation | 21 CFR 878.4680 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
A nonpowered, single patient, portable suction apparatus is a device that consists of a manually operated plastic, disposable evacuation system intended to provide a vacuum for suction drainage of surgical wounds.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
Recent Cleared Devices (20 of 96)
Showing 20 most recent of 96 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K972703 | REDYROB-CLOSED WOUND DRAINAGE SYSTEM | B.Braun Medical, Inc. | Oct 1, 1997 | SESE |
| K971036 | ODONTIT AUTOGENOUS BONE COLLECTION DEVICE | Interpore Intl. | Jun 3, 1997 | SESE |
| K963839 | CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500 | Cordis Corp. | Dec 12, 1996 | SESE |
| K960099 | PENROSE DRAIN MODELS 6001 - 6007 | Sil-Med Corp. | Mar 11, 1996 | SESE |
| K950754 | MACRO SUCTION TUBE MODEL NO 10061 | Dlp, Inc. | Apr 25, 1995 | SESE |
| K936223 | PRESSURE IRRIGATING SYSTEM | Level 1 Technologies, Inc. | May 12, 1994 | SESE |
| K930615 | AUTOVAC CLOSED WOUND SUCTION SYSTEM | Boehringer Laboratories | Feb 22, 1994 | SESE |
| K933319 | BIRTCHER GS-9480 INTEGRATED 3-CHIP CAMERA/XENON LIGHT SOURCE VISUALIZATION SYSTEM | Birtcher Medical Systems, Inc. | Oct 27, 1993 | SESE |
| K933306 | IMC 5.0MM IRRIGATION/ASPIRATION PROBE W/HOLES | Inman Medical Corp. | Oct 5, 1993 | SESE |
| K933305 | IMC 5.0MM IRRIGATION/ASPIRATION PROBE | Inman Medical Corp. | Oct 5, 1993 | SESE |
| K933170 | INMAN POOLE TIP SUCTION PROBE W/TUBING KIT | Inman Medical Corp. | Sep 16, 1993 | SESE |
| K931950 | POOLE TIP SUCTION PROBE | Mayaguez Medical Center | Aug 11, 1993 | SESE |
| K931856 | 5.0 MM IRRIGATION/ASPIRATION PROBE | Mayaguez Medical Center | Aug 10, 1993 | SESE |
| K925024 | ORC TAPPERED IRRIGATING PROBE | O.R. Concepts, Inc. | May 21, 1993 | SESE |
| K923908 | # 9455 AND #9457 POOLE TIP SUCTION PROBE | O.R. Concepts, Inc. | May 17, 1993 | SESE |
| K920819 | ABDOVAC (TM), BELLOVAC (TM) AND EXUDRAIN | Astra Meditec AB | Mar 24, 1993 | SESK |
| K925989 | KENDALL TRU-CLOSE INFECTION CONTROL EVACUATOR | Kendall Healthcare Products Co. Div.Of Tyco Health | Feb 26, 1993 | SESE |
| K925749 | KENDALL TRU-CLOSE(TM) SUCTION RESERVOIR, 150 ML | Kendall Healthcare Products Co. Div.Of Tyco Health | Feb 1, 1993 | SESE |
| K922895 | J-VAC BULB SUCTION RESERVOIR | Johnson & Johnson Medical, Inc. | Sep 15, 1992 | SESE |
| K915867 | SOLCOVAC WOUND DRAINAGE SYSTEM | Solco Basle, Inc. | Aug 14, 1992 | SESK |
Top Applicants
- Snyder Laboratories, Inc. — 5 clearances
- Sherwood Medical Co. — 4 clearances
- Pudenz-Schulte Medical Research Corp. — 4 clearances
- Davol, Inc. — 4 clearances
- Inman Medical Corp. — 3 clearances
