FDA product code GCY: Apparatus, Suction, Single Patient Use, Portable, Nonpowered
GCY is the FDA product code for apparatus, suction, single patient use, portable, nonpowered. It is a Class I device, regulated under 21 CFR 878.4680 and reviewed by the General and Plastic Surgery panel. FDA has cleared 96 510(k) submissions under GCY, from 66 different applicants. The average 510(k) review took 64 days (median 36). FDA has posted 107 recalls for GCY devices.
Classification
| Field | Value |
|---|---|
| Device name | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| Device class | Class I |
| Regulation | 21 CFR 878.4680 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every GCY clearance
Top GCY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Snyder Laboratories, Inc. | 5 | 1980-04-16 |
| Davol, Inc. | 4 | 1992-03-26 |
| Sherwood Medical Co. | 4 | 1982-06-21 |
| Pudenz-Schulte Medical Research Corp. | 4 | 1982-03-08 |
| Inman Medical Corp. | 3 | 1993-10-05 |
61 more applicants have GCY clearances. See the full list in Caduvo.
Most recent GCY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K972703 | B.Braun Medical, Inc. | REDYROB-CLOSED WOUND DRAINAGE SYSTEM | 1997-10-01 | 75 |
| K971036 | Interpore Intl. | ODONTIT AUTOGENOUS BONE COLLECTION DEVICE | 1997-06-03 | 75 |
| K963839 | Cordis Corp. | CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500 | 1996-12-12 | 79 |
| K960099 | Sil-Med Corp. | PENROSE DRAIN MODELS 6001 - 6007 | 1996-03-11 | 60 |
| K950754 | Dlp, Inc. | MACRO SUCTION TUBE MODEL NO 10061 | 1995-04-25 | 67 |
Recalls for GCY devices
107 product recalls in 18 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-11-05.
| Year | Recalls |
|---|---|
| 2017 | 13 |
| 2018 | 1 |
Frequently asked questions
What is FDA product code GCY?
GCY is the FDA product code for apparatus, suction, single patient use, portable, nonpowered. It is a Class I device, regulated under 21 CFR 878.4680 and reviewed by the General and Plastic Surgery panel.
What device class is GCY?
Class I, regulation 21 CFR 878.4680. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code GCY?
Across 96 cleared submissions the average was 64 days from receipt to decision (median 36).
Which companies have the most GCY clearances?
Snyder Laboratories, Inc. (5); Davol, Inc. (4); Sherwood Medical Co. (4); Pudenz-Schulte Medical Research Corp. (4); Inman Medical Corp. (3).
Have GCY devices been recalled?
Yes: 107 product recalls across 18 recall events; the most recent began 2018-11-05.
Next steps
- Run an FDA pathway report with predicate devices for product code GCY
- Run a recall and safety report across every GCY manufacturer
- Watch product code GCY for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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