Product code GCY
- Device name
- Apparatus, Suction, Single Patient Use, Portable, Nonpowered
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4680
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K972703 | REDYROB-CLOSED WOUND DRAINAGE SYSTEM | B.Braun Medical, Inc. | 1997-10-01 |
| K971036 | ODONTIT AUTOGENOUS BONE COLLECTION DEVICE | Interpore Intl. | 1997-06-03 |
| K963839 | CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500 | Cordis Corp. | 1996-12-12 |
| K960099 | PENROSE DRAIN MODELS 6001 - 6007 | Sil-Med Corp. | 1996-03-11 |
| K950754 | MACRO SUCTION TUBE MODEL NO 10061 | Dlp, Inc. | 1995-04-25 |
| K936223 | PRESSURE IRRIGATING SYSTEM | Level 1 Technologies, Inc. | 1994-05-12 |
| K930615 | AUTOVAC CLOSED WOUND SUCTION SYSTEM | Boehringer Laboratories | 1994-02-22 |
| K933319 | BIRTCHER GS-9480 INTEGRATED 3-CHIP CAMERA/XENON LIGHT SOURCE VISUALIZATION SYSTEM | Birtcher Medical Systems, Inc. | 1993-10-27 |
| K933305 | IMC 5.0MM IRRIGATION/ASPIRATION PROBE | Inman Medical Corp. | 1993-10-05 |
| K933170 | INMAN POOLE TIP SUCTION PROBE W/TUBING KIT | Inman Medical Corp. | 1993-09-16 |
| K931950 | POOLE TIP SUCTION PROBE | Mayaguez Medical Center | 1993-08-11 |
| K931856 | 5.0 MM IRRIGATION/ASPIRATION PROBE | Mayaguez Medical Center | 1993-08-10 |
| K925024 | ORC TAPPERED IRRIGATING PROBE | O.R. Concepts, Inc. | 1993-05-21 |
| K923908 | # 9455 AND #9457 POOLE TIP SUCTION PROBE | O.R. Concepts, Inc. | 1993-05-17 |
| K920819 | ABDOVAC (TM), BELLOVAC (TM) AND EXUDRAIN | Astra Meditec AB | 1993-03-24 |
| K925989 | KENDALL TRU-CLOSE INFECTION CONTROL EVACUATOR | Kendall Healthcare Products Co. Div.Of Tyco Health | 1993-02-26 |
| K925749 | KENDALL TRU-CLOSE(TM) SUCTION RESERVOIR, 150 ML | Kendall Healthcare Products Co. Div.Of Tyco Health | 1993-02-01 |
| K922895 | J-VAC BULB SUCTION RESERVOIR | Johnson & Johnson Medical, Inc. | 1992-09-15 |
| K915867 | SOLCOVAC WOUND DRAINAGE SYSTEM | Solco Basle, Inc. | 1992-08-14 |
| K915536 | DAVOL 100CC SILICONE CLOSED WOUND DRAINAGE EVAC | Davol, Inc. | 1992-03-26 |
| K910167 | MICROTEK-HERITAGES SILICONE BULB EVACUATION SYSTEM | Microbio-Medics, Inc. | 1991-04-15 |
| K905733 | SEROMA-CATH CLOSE DRAINAGE SYSTEM | Dawn Medical | 1991-01-28 |
| K901742 | INAMED SMALL DRAIN SYSTEM | Inamed Development Co. | 1990-05-07 |
| K901764 | INAMED CONVERTIBLE DRAIN SYSTEM | Inamed Development Co. | 1990-05-07 |
| K896491 | INAMED CLOSED-WOUND DRAIN SYSTEM | Inamed Development Co. | 1990-01-08 |
| K896803 | CLOSED WOUND RESERVOIR | Westmark, Sterile Packing Systems, Inc. (Sps) | 1989-12-27 |
| K883982 | DRENOVAC | Iberhospitex, S.A. | 1989-02-23 |
| K883472 | CLOSED WOUND SUCTION DEVICE | Westmark, Sterile Packing Systems, Inc. (Sps) | 1988-10-18 |
| K883433 | AMBU TWIN PUMP - (MANUAL SUCTION PUMP) | Ambu, Inc. | 1988-09-02 |
| K881036 | HEMO SUC NUMBER HS100-HS205 | Instrumental Medico Croquevielle S.A. | 1988-06-20 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00848530095222 | Tracheostomy and Suction Accessory | Sunset Healthcare Solutions, Inc. | 2025-06-03 |
| 00848530095215 | Closed Suction | Sunset Healthcare Solutions, Inc. | 2024-06-19 |
| 00848530095352 | Closed Suction | Sunset Healthcare Solutions, Inc. | 2024-06-19 |
| 00848530095345 | Closed Suction | Sunset Healthcare Solutions, Inc. | 2024-06-19 |
| 00848530095338 | Closed Suction | Sunset Healthcare Solutions, Inc. | 2024-06-19 |
| 00848530095321 | Closed Suction | Sunset Healthcare Solutions, Inc. | 2024-06-19 |
| 00848530095307 | Closed Suction | Sunset Healthcare Solutions, Inc. | 2024-06-19 |
| 00848530095291 | Closed Suction | Sunset Healthcare Solutions, Inc. | 2024-06-19 |
| 00848530095284 | Closed Suction | Sunset Healthcare Solutions, Inc. | 2024-06-19 |
| 00848530095277 | Closed Suction | Sunset Healthcare Solutions, Inc. | 2024-06-19 |
| 00848530095260 | Closed Suction | Sunset Healthcare Solutions, Inc. | 2024-06-19 |
| 00848530095253 | Closed Suction | Sunset Healthcare Solutions, Inc. | 2024-06-19 |
| 00848530095239 | Closed Suction | Sunset Healthcare Solutions, Inc. | 2024-06-19 |
| 00848530095208 | Closed Suction | Sunset Healthcare Solutions, Inc. | 2024-06-19 |
| 00848530095192 | Closed Suction | Sunset Healthcare Solutions, Inc. | 2024-06-19 |
| 00848530095109 | Closed Suction | Sunset Healthcare Solutions, Inc. | 2024-06-19 |
| 00848530095093 | Closed Suction | Sunset Healthcare Solutions, Inc. | 2024-06-19 |
| 00848530093129 | Suction Kit | Sunset Healthcare Solutions, Inc. | 2024-05-31 |
| 00848530095185 | Deluxe Closed Suction System | Sunset Healthcare Solutions, Inc. | 2024-05-29 |
| 00848530095178 | Deluxe Closed Suction System | Sunset Healthcare Solutions, Inc. | 2024-05-29 |
| 00848530095161 | Deluxe Closed Suction System | Sunset Healthcare Solutions, Inc. | 2024-05-29 |
| 00848530095147 | Deluxe Closed Suction System | Sunset Healthcare Solutions, Inc. | 2024-05-29 |
| 00848530095314 | Deluxe Closed Suction System | Sunset Healthcare Solutions, Inc. | 2024-05-29 |
| 00848530095246 | Deluxe Closed Suction System | Sunset Healthcare Solutions, Inc. | 2024-05-28 |
| 00848530095154 | Deluxe Closed Suction System | Sunset Healthcare Solutions, Inc. | 2024-05-28 |
| 00848530095130 | Deluxe Closed Suction System | Sunset Healthcare Solutions, Inc. | 2024-05-28 |
| 00848530095123 | Deluxe Closed Suction System | Sunset Healthcare Solutions, Inc. | 2024-05-28 |
| 00848530095116 | Deluxe Closed Suction System | Sunset Healthcare Solutions, Inc. | 2024-05-28 |
| 00848530061272 | Rubber Suction Elbow Connectors | Sunset Healthcare Solutions, Inc. | 2018-07-31 |
| 00848530061562 | Rubber Suction Elbow Connector | Sunset Healthcare Solutions, Inc. | 2018-07-31 |