GCY — Apparatus, Suction, Single Patient Use, Portable, Nonpowered Class I
FDA product code GCY covers "Apparatus, Suction, Single Patient Use, Portable, Nonpowered", a Class I medical device regulated under 21 CFR 878.4680. Submissions are reviewed by the General, Plastic Surgery panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GCY
- Device Class
- Class I
- Regulation Number
- 878.4680
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K972703 | b.braun medical | REDYROB-CLOSED WOUND DRAINAGE SYSTEM | October 1, 1997 |
| K971036 | interpore intl | ODONTIT AUTOGENOUS BONE COLLECTION DEVICE | June 3, 1997 |
| K963839 | cordis | CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500 | December 12, 1996 |
| K960099 | sil-med | PENROSE DRAIN MODELS 6001 - 6007 | March 11, 1996 |
| K950754 | dlp | MACRO SUCTION TUBE MODEL NO 10061 | April 25, 1995 |
| K936223 | level 1 technologies | PRESSURE IRRIGATING SYSTEM | May 12, 1994 |
| K930615 | boehringer laboratories | AUTOVAC CLOSED WOUND SUCTION SYSTEM | February 22, 1994 |
| K933319 | birtcher medical systems | BIRTCHER GS-9480 INTEGRATED 3-CHIP CAMERA/XENON LIGHT SOURCE VISUALIZATION SYSTE | October 27, 1993 |
| K933305 | inman medical | IMC 5.0MM IRRIGATION/ASPIRATION PROBE | October 5, 1993 |
| K933306 | inman medical | IMC 5.0MM IRRIGATION/ASPIRATION PROBE W/HOLES | October 5, 1993 |
| K933170 | inman medical | INMAN POOLE TIP SUCTION PROBE W/TUBING KIT | September 16, 1993 |
| K931950 | mayaguez medical center | POOLE TIP SUCTION PROBE | August 11, 1993 |
| K931856 | mayaguez medical center | 5.0 MM IRRIGATION/ASPIRATION PROBE | August 10, 1993 |
| K925024 | o.r. concepts | ORC TAPPERED IRRIGATING PROBE | May 21, 1993 |
| K923908 | o.r. concepts | # 9455 AND #9457 POOLE TIP SUCTION PROBE | May 17, 1993 |
| K920819 | astra meditec | ABDOVAC (TM), BELLOVAC (TM) AND EXUDRAIN | March 24, 1993 |
| K925989 | kendall healthcare products co. div.of tyco health | KENDALL TRU-CLOSE INFECTION CONTROL EVACUATOR | February 26, 1993 |
| K925749 | kendall healthcare products co. div.of tyco health | KENDALL TRU-CLOSE(TM) SUCTION RESERVOIR, 150 ML | February 1, 1993 |
| K922895 | johnson and johnson medical | J-VAC BULB SUCTION RESERVOIR | September 15, 1992 |
| K915867 | solco basle | SOLCOVAC WOUND DRAINAGE SYSTEM | August 14, 1992 |