Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4680](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4680) → GCY — Apparatus, Suction, Single Patient Use, Portable, Nonpowered # GCY · Apparatus, Suction, Single Patient Use, Portable, Nonpowered _General, Plastic Surgery · 21 CFR 878.4680 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GCY ## Overview - **Product Code:** GCY - **Device Name:** Apparatus, Suction, Single Patient Use, Portable, Nonpowered - **Regulation:** [21 CFR 878.4680](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4680) - **Device Class:** 1 - **Review Panel:** [General, Plastic Surgery](/submissions/SU) ## 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](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GCY/K972703.md) | REDYROB-CLOSED WOUND DRAINAGE SYSTEM | B.Braun Medical, Inc. | Oct 1, 1997 | SESE | | [K971036](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GCY/K971036.md) | ODONTIT AUTOGENOUS BONE COLLECTION DEVICE | Interpore Intl. | Jun 3, 1997 | SESE | | [K963839](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GCY/K963839.md) | CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500 | Cordis Corp. | Dec 12, 1996 | SESE | | [K960099](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GCY/K960099.md) | PENROSE DRAIN MODELS 6001 - 6007 | Sil-Med Corp. | Mar 11, 1996 | SESE | | [K950754](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GCY/K950754.md) | MACRO SUCTION TUBE MODEL NO 10061 | Dlp, Inc. | Apr 25, 1995 | SESE | | [K936223](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GCY/K936223.md) | PRESSURE IRRIGATING SYSTEM | Level 1 Technologies, Inc. | May 12, 1994 | SESE | | [K930615](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GCY/K930615.md) | AUTOVAC CLOSED WOUND SUCTION SYSTEM | Boehringer Laboratories | Feb 22, 1994 | SESE | | [K933319](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GCY/K933319.md) | BIRTCHER GS-9480 INTEGRATED 3-CHIP CAMERA/XENON LIGHT SOURCE VISUALIZATION SYSTEM | Birtcher Medical Systems, Inc. | Oct 27, 1993 | SESE | | [K933306](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GCY/K933306.md) | IMC 5.0MM IRRIGATION/ASPIRATION PROBE W/HOLES | Inman Medical Corp. | Oct 5, 1993 | SESE | | [K933305](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GCY/K933305.md) | IMC 5.0MM IRRIGATION/ASPIRATION PROBE | Inman Medical Corp. | Oct 5, 1993 | SESE | | [K933170](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GCY/K933170.md) | INMAN POOLE TIP SUCTION PROBE W/TUBING KIT | Inman Medical Corp. | Sep 16, 1993 | SESE | | [K931950](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GCY/K931950.md) | POOLE TIP SUCTION PROBE | Mayaguez Medical Center | Aug 11, 1993 | SESE | | [K931856](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GCY/K931856.md) | 5.0 MM IRRIGATION/ASPIRATION PROBE | Mayaguez Medical Center | Aug 10, 1993 | SESE | | [K925024](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GCY/K925024.md) | ORC TAPPERED IRRIGATING PROBE | O.R. Concepts, Inc. | May 21, 1993 | SESE | | [K923908](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GCY/K923908.md) | # 9455 AND #9457 POOLE TIP SUCTION PROBE | O.R. Concepts, Inc. | May 17, 1993 | SESE | | [K920819](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GCY/K920819.md) | ABDOVAC (TM), BELLOVAC (TM) AND EXUDRAIN | Astra Meditec AB | Mar 24, 1993 | SESK | | [K925989](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GCY/K925989.md) | KENDALL TRU-CLOSE INFECTION CONTROL EVACUATOR | Kendall Healthcare Products Co. Div.Of Tyco Health | Feb 26, 1993 | SESE | | [K925749](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GCY/K925749.md) | KENDALL TRU-CLOSE(TM) SUCTION RESERVOIR, 150 ML | Kendall Healthcare Products Co. Div.Of Tyco Health | Feb 1, 1993 | SESE | | [K922895](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GCY/K922895.md) | J-VAC BULB SUCTION RESERVOIR | Johnson & Johnson Medical, Inc. | Sep 15, 1992 | SESE | | [K915867](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GCY/K915867.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GCY](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GCY) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com